Principal Design Quality Engineer
Principal Design Quality Engineer Location: Boston (Hybrid) A leading biotech is seeking a Principal Design Quality Engineer to lead design quality functions for their leading combination device. The Principal Design Quality Engineer will primarily be responsible for providing QA support to Design and Development and for product related functions. Responsibilities: Lead Design functions - design inputs/outputs, risk management, design V&V testing, design transfer, etc. Support for design-related continuous improvement, design changes, and market expansion QA oversight of root cause investigations, CAPAs, change controls, complaint trending, and post-market surveillance activities QA support for product related audits, regulatory inspections, and regulatory submissions Work with component suppliers - change management and supplier audit support Qualifications: 10 years of relevant experience within medical device, combination product experience preferred Experience leading Design Quality through the entire product lifecycle Experience with design history, human factors, and risk management files If this sounds interesting, please don't hesitate to apply!
Negotiable
Boston
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Engineering Manager
Summary: A well-funded Contract Manufacturer in growth mode is searching for an Engineering Manager to oversee the Manufacturing and Process Engineering teams. As Engineering Manager, you will manage and provide direct and indirect supervision to skilled and intermediate-level professional employees performing diverse roles in more than one function or unit, while providing direction, coordination, education, and tools needed to. Detailed Description: Performs tasks such as, but not limited to, the following: Supports generation of performance metrics for products and processes of moderate complexity and drives the team to achieve Manufacturing and Production Goals set by management , following ISO standards Leads Continuous Improvement Programs (CIP) in support of customer requirements and expectations that are considered medium in scale and moderately complex. Mentors and trains personnel in the practices of Manufacturing and Production Resolves customer issues of moderate difficulty using quality tools: Root Cause Analysis and Corrective Actions that are effective and timely. Supports new customer qualification and New product introduction with supplier assessments, First Article Inspections, and oversees generation of product documentation for products/programs of moderate risk. Knowledge/Skills/Competencies: In-depth knowledge of quality metrics, ISO standards, and processes. Knowledge of Lean and Six Sigma Manufacturing processes and controls including: Statistical Process Control (SPC), 5S, and Value Stream Mapping (VSM). Strong knowledge of Quality Management tools including: Failure Mode and Effect Analysis (FMEA). Strong Project Management Skills. Ability to coordinate a wide variety of resources to meet production quality and quantity metrics. Ability to effectively communicate with a wide variety of internal and external customers. Ability to effectively lead, manage, train, and motivate a diverse group of employees to achieve high production levels within tight time deadlines and in a highly dynamic manufacturing environment. Ability to use some or all of the following PC applications: Google Applications, Word, Excel, and PowerPoint. Excellent knowledge of manufacturing processes.
US$130000 - US$145000 per year
Minneapolis
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Auditor
Job Description: A leading provider of quality and safety solutions to many of the world's top-recognized brands and companies is actively seeking a Medical Device Auditor to join our Business Assurance Team remotely. This is an excellent opportunity to grow a versatile career in Medical Device Auditing. Our Business Assurance team goes beyond testing, inspection, and certification to examine the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and peace of mind that a client's operating procedures, systems, and people are functioning correctly to provide a competitive advantage in the marketplace. Key Responsibilities: Lead and participate as an assessor during all phases of a client's management system audit in accordance with the company's accredited certification program. Serve as the primary interface with clients before and during auditing activities. Train lower-graded auditors through witness audits, technical support, and education of both clients and sales force as needed. Conduct audits of client management systems for compliance with established standards, client and industry requirements, government regulations, and other relevant standards, specifically ISO 13485 and GMP regulatory requirements for the medical device, pharmaceutical, and cosmetic industries. Assist clients with questions relevant to the audit and certification process. Act as Lead Auditor or team member during audits. Coordinate audit activities with team members and liaise with clients regarding audit processes. Review client quality management system documentation and verify evidence of compliance and non-compliance. Prepare audit reports, review audit results with the assessment team, and present findings to clients and certification boards as required. Assist with corrective action requirements resulting from assessments and participate in audit meetings. Provide technical assistance and support management in continuous improvement initiatives. Qualifications: Bachelor's degree in a science or technical field (e.g., biology, microbiology, chemistry, biochemistry, engineering, human physiology, medicine, pharmacy, physics) or equivalent combination of relevant education and work experience. Minimum of 4 years of full-time work experience in the medical device or related industry (design, development, testing, quality assurance/control). Minimum of 2 years in a quality management systems environment (auditing, CAPA, complaints management review). Completed Lead Auditor training for any standard (preferably ISO 13485 and/or relevant regulatory requirements); training provided if needed. Strong communication and interpersonal skills. Excellent organizational, analytical, and computer skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Effective time management skills and the ability to travel extensively (3-5 nights per week). Valid unrestricted driver's license and the ability to operate a motor vehicle. Preferred Qualifications: Lead Auditor Training with ISO 19011 or ISO 13485 certification. Experience in third-party auditing and management systems. Knowledge of regulatory requirements for medical devices and pharmaceuticals in regions such as the EU, US, Australia, Japan, Brazil, and Canada. Experience implementing/auditing to ISO 13485, ISO 14971, and related standards. Training/experience in quality tools (e.g., Kaizen, lean manufacturing). Experience in a wide range of medical devices. Physical Requirements: Ability to ascend/descend ladders, stairs, and ramps using feet and legs and/or hands and arms. Stand for sustained periods and walk to accomplish tasks. Communicate well through spoken word, conveying detailed, accurate information and instructions. Hear well, perceiving sounds with or without correction. Exert up to 10 pounds of force occasionally to lift, carry, push, pull, or move objects. Have close visual acuity to perform activities such as preparing and analyzing data, viewing a computer monitor, reading, and writing reports. About Us: We are a leading provider of Total Quality Assurance solutions to industries worldwide. Our network includes over 1,000 laboratories and offices in more than 100 countries. Join our global network of passionate people delivering superior customer service with a purpose of bringing quality, safety, and sustainability to life. Diversity Statement: We value diversity and are an Equal Employment Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.
Negotiable
California
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Senior Metrologist
Senior Metrologist Location: Tampa, FL Working situation: Onsite Level: Mid-Level, Individual Contributor Our client, a mid-sized, successful and global biotechnology firm is looking to add a Senior Metrologist responsible for leading and managing all aspects of metrology within their organization. The Senior Metrologist is responsible for ensuring the accuracy and reliability of our measurement standards, equipment calibration, and adherence to regulatory requirements. You will play a crucial role in maintaining the quality and precision of their products and processes. The Senior Metrologist will: Evaluate, select, and implement new metrology equipment and technologies Manage the maintenance and repair of existing equipment Develop and maintain calibration procedures, schedules, and documentation for all measurement equipment and instruments Work closely with engineering, manufacturing, quality assurance, and other departments to support product development and manufacturing processes Continuously improve metrology processes to enhance efficiency, accuracy, and reliability The Senior Metrologist has the following qualifications: Bachelor's Degree in Engineering, or related fields Minimum of 2+ years of metrology experience Knowledge of relevant regulations and standards such as the FDA Company Benefits: Competitive 401K program, health insurance, and HSA accounts Casual dress days Lunch & Learns
Negotiable
Tampa
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Department Manager - Wireless Technology and EMC Laboratories
A leading provider of testing and certification services, specializing in Wireless Technology and Electromagnetic Compatibility (EMC). With state-of-the-art laboratories, we are dedicated to ensuring product compliance and reliability for our clients across various industries. We are seeking an experienced and dynamic individual to join our team as the Department Manager for Wireless Technology and EMC Laboratories. In this role, you will be responsible for leading and overseeing the day-to-day operations of our laboratories, ensuring the highest standards of testing and certification services. Key Responsibilities: Leadership: Provide strong leadership to the team of engineers and technicians within the Wireless Technology and EMC laboratories. Foster a collaborative and innovative work environment to drive excellence in testing and certification processes. Operational Oversight: Manage and optimize laboratory resources, ensuring efficient workflows and timely project delivery. Implement and maintain quality control measures to meet industry standards and client expectations. Technical Expertise: Stay abreast of advancements in wireless technology and EMC testing methodologies. Act as a subject matter expert, providing guidance and support to the team on complex technical issues. Client Engagement: Build and maintain strong relationships with clients, understanding their testing and certification needs. Collaborate with sales and business development teams to identify new opportunities and contribute to client acquisition. Location Flexibility: Willingness to spend time in multiple locations, overseeing operations and ensuring a cohesive team environment. Compliance and Standards: Ensure that all testing activities comply with relevant industry standards and regulatory requirements. Keep abreast of changes in standards and regulations and update laboratory procedures accordingly. Qualifications: Bachelor's or Master's degree in Electrical Engineering, Telecommunications, or a related field. Excellent leadership, communication, and interpersonal skills. Proven experience in a managerial role within a testing laboratory, preferably in the Wireless Technology and EMC domain. Familiarity with industry standards is considered an advantage.
Negotiable
Oslo
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Subject manager Management System Certification
A leading supplier of testing, inspection, and certification services. We help companies ensure their products and systems meet the necessary national and international standards and regulations. Our expertise covers a wide range of industries, including electrical and electronic products, medical devices, ICT products, and more. About Management Systems: Within Management Systems, we offer certification services based on ISO standards such as ISO 9001 (quality management), ISO 14001 (environmental management), ISO/IEC 27001 (information security), and more. Our services help organizations implement, maintain, and improve effective management systems that ensure compliance with standards, reduce risk, and improve operations. Through our certifications, we help customers build trust with their stakeholders and achieve sustainable growth. The subject manager will be responsible for: Monitoring and ensuring compliance with the latest ISO standards and regulations Providing technical guidance to internal and external stakeholders Maintaining high-quality service delivery The role requires a deep understanding of ISO standards such as ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 27701, ISO 22000, ISO 13485, ISO 22301, and ISO 50001, as well as other relevant certifications. Main tasks: Regulatory Compliance: Monitor and keep up to date on changes in ISO standards and relevant authority requirements. Communicate updates and changes in standards to relevant teams and ensure that all documentation meets the new requirements. Technical Guidance: Provide expert advice on technical challenges to sales teams, audit managers, administrative staff, and customers worldwide. Support personnel certification processes as needed. Training and Development: Ensure compliance with the competency requirements of the team and manage necessary registrations. Prepare and conduct technical training sessions and workshops for internal staff and contracted staff. Quality Assurance: Participate in assessments from accreditation bodies. Ensure that all audit and certification processes are in line with the highest quality standards. Cooperation and Communication: Work closely with the management team to align the MSC strategy with the company's overall goals. Participate in committee work related to personnel certification and contribute to the development of best practices. Qualifications: Higher education, minimum Bachelor's level Extensive experience with ISO standards and certification processes Strong communication and interpersonal skills Ability to interpret and apply regulatory changes effectively Experience with training and supervision of employees Additional Skills: Proficiency in the use of relevant software tools and databases Strong analytical and problem-solving skills
Negotiable
Oslo
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Audit manager
One of Norway's largest certification companies within system certification, where the standards for quality, environment, energy, working environment, information security, and food safety are central. Our customers are in a wide range of industries, from industry, public sector, service companies, food, and healthcare. The customer portfolio is also varied in terms of size, number of locations, type of organization, and number of standards to which the customers are certified. We have a positive development and an increasing number of assignments, and therefore need more audit managers. For the position, the following qualifications and background are desirable: Higher education. A minimum of 10 years of relevant professional experience, including a minimum of 5 years from a managerial position with results and personnel responsibility. Experience from the Norwegian or international industrial sector, preferably with a contractor, construction, energy, or electromechanical background. Preferably experience from establishing management systems and carrying out audits. Analytical, independent, results-oriented, and flexible. Good communication skills, both Norwegian or Swedish and English orally and in writing. Tasks you will spend the working day on: Plan and carry out audits in accordance with, among others, the management standards for quality ISO 9001, environment ISO 14001, and energy ISO 50001. Depending on qualifications, this can be extended with information security ISO/IEC 27001 and working environment ISO 45001. Be an independent third-party actor, which helps to lift the customer's quality and safety work. Further develop a good starting portfolio of already certified organizations and, if necessary, contribute to sales on new inquiries. We can offer: Responsibility for one's own portfolio, with the possibility to manage the execution time on one's own in collaboration with the customers and in accordance with accreditation-related requirements. Distinctly independent work, while at the same time you will receive support from the management. Good professional development together with skilled colleagues. Exciting challenges and varied tasks in a hectic environment. Competitive pay and working conditions. Flexible working hours. Professional responsibilities within energy management and environmental management can be assessed for candidates with a solid professional background. The position entails travel activities, primarily in Norway.
Negotiable
Oslo
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Quality Systems Director
Company Description: We are seeking an experienced Quality Systems Director to lead the development, implementation, and management of comprehensive quality management systems with a large chemicals manufacturing company. As the Quality Systems Director, you will be responsible for ensuring that our quality systems align with regulatory requirements, industry standards, and company objectives to consistently deliver high-quality products to our customers. Key Responsibilities: Strategic Leadership: Develop and execute a strategic vision for the company's quality management systems, aligning with business goals and objectives. Quality Management Systems Development: Design and implement robust quality management systems (QMS) across all functions, ensuring compliance with ISO standards (e.g., ISO 9001, ISO 14001) and relevant regulatory requirements (e.g., REACH, OSHA). Continuous Improvement: Drive continuous improvement initiatives to enhance quality processes, reduce defects, and optimize operational efficiencies using methodologies such as Lean Six Sigma. Regulatory Compliance: Ensure adherence to all applicable regulatory requirements and standards for chemical manufacturing, maintaining necessary certifications and permits. Risk Management: Implement effective risk assessment and mitigation strategies within the QMS framework to manage quality-related risks across operations. Audits and Inspections: Lead internal and external quality audits and inspections, addressing findings and implementing corrective actions as needed. Qualifications: Bachelor's degree in Chemistry, Chemical Engineering, or related field; advanced degree preferred. Minimum 10 years of progressive experience in quality management within the chemicals manufacturing industry, with at least 5 years in a leadership role overseeing QMS. Strong knowledge of ISO standards and regulatory requirements applicable to chemical manufacturing (e.g., REACH, GHS). Proven track record of successfully implementing and managing QMS, preferably in a global manufacturing environment. Experience with Lean Six Sigma methodologies and tools for process improvement. Excellent communication, leadership, and interpersonal skills, with the ability to influence and collaborate effectively across departments and with external stakeholders. Certification in quality management (e.g., CQM, Six Sigma Black Belt) is highly desirable.
Negotiable
Greenville
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Food Safety Quality Assurance Director
Food Safety Quality Assurance Director Location: Atlanta, Georgia Working Situation: Hybrid Level: Senior Level We are seeking a detail-oriented and experienced Food Safety Quality Assurance Director to join our team. The FSQA Director will play a pivotal role in ensuring the safety, quality, and compliance of our products. Responsible for overseeing all aspects of food safety and quality assurance programs, you will develop strategies, implement systems, and lead initiatives to uphold regulatory standards and enhance consumer confidence in our brand. The Food Safety Quality Assurance Director will be responsible for: Develop and execute comprehensive food safety and quality assurance strategies aligned with organizational goals. Ensure adherence to all relevant food safety regulations and standards (e.g., FDA, USDA, HACCP) through effective policy implementation and proactive monitoring Implement and maintain robust quality management systems (QMS) across all stages of production, from sourcing raw materials to product distribution, to ensure consistency and excellence in product quality. Conduct thorough risk assessments to identify potential hazards and develop mitigation strategies. Proactively address food safety risks and implement corrective actions as necessary. Coordinate internal and external audits and inspections to evaluate compliance with regulatory requirements and internal standards. Prepare for audits and ensure corrective actions are implemented promptly. Develop and deliver comprehensive training programs for employees at all levels to promote awareness of food safety practices, quality standards, and regulatory requirements. Collaborate with suppliers to establish and maintain quality assurance expectations and ensure compliance with specifications. Monitor supplier performance and implement improvement initiatives as needed. Lead continuous improvement initiatives to enhance food safety and quality assurance processes, optimize operational efficiencies, and drive organizational excellence. Develop and implement crisis management protocols to effectively manage food safety incidents or product recalls, minimizing potential impact on consumers and the company's reputation. The Food Safety Quality Assurance Director will have the following qualifications: Bachelor's degree in Food Science, Microbiology, Chemistry, or related field. Advanced degree preferred. Minimum of 7-10 years of progressive experience in food safety and quality assurance, with at least 3 years in a leadership or managerial role. In-depth knowledge of food safety regulations, standards, and best practices (e.g., FSMA, GFSI, ISO). Strong leadership skills with the ability to inspire and develop a team, fostering a culture of accountability and continuous improvement. Excellent communication, negotiation, and interpersonal skills. Ability to collaborate effectively with cross-functional teams and external stakeholders. If you are interested in this Food Safety Quality Assurance Director opportunity, apply now!
US$120000 - US$185000 per annum
Atlanta
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Quality Assurance Manager - Bakery
Quality Assurance Manager - Bakery Location: Miami-Fort Lauderdale Area Working Situation: Hybrid Level: Mid-Senior Level We are seeking an experienced Quality Assurance Manager to join our team and oversee all aspects of food safety, quality, and consistency of the Bakery Commodities. The ideal candidate will have a strong background in food safety regulations, quality management systems, and a proven track record of ensuring compliance with industry standards. The successful Quality Assurance Manager will be leading a team and traveling across North America to support FSQA efforts. The Quality Assurance Manager will be responsible for: Monitor and enhance bakery product quality and supplier performance through audits, compliance checks, and complaint handling. Certify facilities and approve new bakery products from suppliers, ensuring they meet standards. Support new product launches and advise Product Innovation and Supply Chain teams. Evaluate supplier performance with standardized testing and reports. Address bakery product complaints and ensure corrective actions are taken. Collaborate on projects to improve food safety, quality, and profitability across various functions and Franchisees. Serve as the QA bakery expert during crises, investigating supply issues and advising on safety actions. Contribute to enhancing the company's QA processes and standards, focusing on the Supplier Quality Scorecard. The Quality Assurance Manager will have the following qualifications: Bachelor's degree in Food Science, Food Technology, or related field. 3+ years of experience in industrial bakery operations, preferably in Food Service/QSR supply. Knowledge of bakery manufacturing, ingredient functionality, and troubleshooting. HACCP Certified with understanding of Product Safety principles. Familiarity with Statistical Process Control (SPC) and bakery quality standards. Minimum travel of 25% expected If you are interested in this Quality Assurance Manager opportunity, apply now!
US$85000 - US$110000 per annum
Miami
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