Our client, a prominent player in the medical device industry, is seeking a dedicated and experienced Quality Control Manager to join their team. With a strong commitment to patient safety and product excellence, they are renowned for their innovative and high-quality medical devices.
We are assisting our client in the search for a talented Quality Control Manager to ensure the quality and compliance of their medical devices. The successful candidate will lead a team of quality control professionals, oversee quality control processes, and maintain the highest standards in product manufacturing.
Key Responsibilities:
- Lead, mentor, and develop a team of quality control specialists, setting clear goals and expectations for performance.
- Develop, implement, and maintain effective quality control systems and procedures to ensure compliance with regulatory standards and industry best practices.
- Coordinate and oversee inspection and testing of medical devices at various stages of production, ensuring adherence to product specifications and quality standards.
- Utilize statistical methods and data analysis to monitor product quality trends, identify areas for improvement, and make data-driven decisions
- Ensure that all quality control processes and documentation are in compliance with relevant regulations, including FDA and ISO standards.
- Collaborate with suppliers to establish and maintain quality standards for incoming materials and components.
- Drive a culture of continuous improvement by identifying opportunities for process optimization and efficiency gains.
- Prepare for and participate in regulatory audits and inspections, providing necessary documentation and support.
- Maintain accurate and complete quality control records and documentation.
Qualifications:
- Bachelor's degree in science relate field Strong knowledge of FDA regulations (21 CFR Part 820) and ISO standards (ISO 13485).
- Proven leadership and team management skills.
- Excellent problem-solving and analytical abilities.
- Exceptional communication and interpersonal skills.
- Detail-oriented with a strong commitment to quality.
- Experience with statistical analysis and quality control tools (e.g., Six Sigma) is a plus.
