Quality Assurance Manager Medical Device Were looking for an experienced Quality Assurance Manager with a proven track record in the medical device industry. In this role, you will lead quality initiatives, oversee compliance, and independently manage regulatory authority audits. Your expertise in Quality Management Systems (QMS), medical device regulations, and audit preparation will be critical in ensuring our operations meet the highest standards for safety, reliability, and compliance.
What You Will Do Evolve Quality Systems: Enhance the Quality Management System (QMS) in alignment with ISO 13485 and other key standards. Lead the Way: Guide and develop the compliance team, fostering professional growth and optimal performance. Collaborate to Improve: Work with cross-functional teams to build a culture of quality, emphasizing collaboration over enforcement. Own Audits: Manage internal and external audits to maintain certifications such as ISO 13485, MDSAP, and MDR. Ensure Supplier Excellence: Oversee supplier audits, qualifications, and ongoing performance assessments. Drive Corrective Actions: Lead the NCR and CAPA processes, conducting root cause analyses and implementing improvements. Train the Team: Create and execute training programs on regulatory requirements, GMP/GDP best practices, and company quality standards. Oversee Batch Reviews: Ensure accuracy and compliance in the batch record review process. Track Success: Monitor quality metrics and KPIs to measure the QMSs effectiveness and identify opportunities for optimization. Handle Customer Feedback: Manage complaint investigations, resolutions, and documentation to meet regulatory standards. Maintain Control: Administer document control processes, including ECO management and follow-up actions. What Were Looking For A bachelors degree in a scientific discipline. At least 5 years of quality management experience in the medical device industry. Deep expertise in ISO 13485, FDA regulations, and related standards. Strong analytical, problem-solving, and communication skills. Leadership experience with a focus on team development. Familiarity with quality management software and tools. Ability to make risk-based decisions and thrive in a dynamic environment. Quality certifications (e.g., CQE, CQA) are a bonus. Why Join Us? Competitive salary with performance-based bonuses. Comprehensive health, dental, and vision coverage. Retirement savings plan with company contributions. Opportunities for professional growth and career advancement. A team-focused, collaborative environment that values innovation. Ready to shape the future of quality assurance in manufacturing? Apply today!
Medical
Dental
Vision
PTO
401K Match