Summary:
As the Quality Systems Engineer, you will ensure the implementation, maintenance, monitoring, and reporting of designated quality system processes to ensure their sufficiency and continual enhancement in an ISO13485 environment. With a primary focus on nonconformance and Corrective and Preventive Action (CAPA) quality systems, this role spearheads and assists in investigations, root cause analyses, corrective actions, and the management of nonconformance and CAPA processes. The ideal candidate possesses a robust background in quality systems, adept problem-solving abilities, and a steadfast commitment to upholding quality standards within the medical device industry.
Key Responsibilities:
- Graphics and Labeling Requirements: Evaluates, edits, and formulates label content according to customer specifications and company protocols.
- Assumes responsibility for label management and reconciliation processes, ensuring accurate documentation of label application and disposal.
- Assists Speed to Market teams during product transfers and collaborates with Production teams on product alterations.
- Updates job jackets, MOM, and related documents to implement product modifications based on reviewed revisions.
- Reviews and supports the assessment of material non-conformances, ensuring proper segregation, disposition, and corrective actions before material release.
- Investigates and addresses customer returns, complaints, and support requests regarding product conformity, implementing necessary corrective actions promptly.
- Review and investigates requested or assigned Corrective Action Requests (CARs) and Corrective and Preventive Actions (CAPAs).
- Supports or conducts compliance audits of Quality System processes, manufacturing areas, and documentation as directed.
- Presents audit findings to process or area management and company leadership as required.
- Assists the Quality System Manager in overseeing external audits from customers and regulatory bodies.
- Manages equipment and gauge calibration resources, ensuring compliance with calibration procedures.
- Supports the maintenance and control of measurement equipment, conducting periodic inspections for usability and addressing user queries or concerns.
- Provides support for equipment preventive maintenance scheduling and work standard enforcement.
- Collaborates with the organization to develop work standards in line with production transfer and improvement initiatives.
- Facilitates air, water, and surface monitoring for viable and particulate counts, coordinating with external suppliers for cleanroom and HEPA testing.
- Contributes to Quality objectives relevant to job responsibilities.
- Undertakes additional duties as assigned by the immediate supervisor.
- Job Closing Responsibilities: Reviews MOM for customer documentation requirements, excluding references to CoCs.
Qualifications: Education and Experience:
- Bachelor's Degree in Life Sciences or a related technical discipline (e.g., biomedical engineering) or field.
- Minimum of 5 years of experience in an ISO 13485 environment.
- Minimum of 5 years of direct experience in nonconformance and CAPA investigation within the medical device industry.
- Previous experience supporting and facilitating internal and external audits within the medical device field.
Certificates, Licenses, Registrations:
- Certification as a quality auditor or similar industry certification.
Benefits:
Full-time team members become eligible for benefits starting the first day of the month following 30 days of employment. These include:
- Health Insurance:
- High Deductible Health Plan (HDHP) with Health Savings Account (HSA) - with an employer contribution of $1,040 annually.
- High Preferred Provider Organization (PPO)
- Low Preferred Provider Organization (PPO)
- Flexible Spending Account (FSA)
- Dental Insurance
- Vision Insurance
- Basic Life Insurance (Employer-paid)
- Supplemental Life Insurance
- Short-term Disability Insurance (Employer-paid)
- Long-term Disability Insurance
- 401(k) Plan with a 4% Employer Match
- Paid Time Off (accrued at 120 hours per year)*
- 9 Paid Holidays
- Access to Continuing Education and Seminar Programs
- Employee Assistance Program (EAP)
- Fitness Room Access
