Position Title: Senior Manager of Quality Assurance
Location: SF Bay Area
Department: Quality Assurance
Company Overview
Medical device company dedicated to developing innovative and life-saving technologies. Our mission is to improve patient outcomes by providing high-quality, reliable, and safe medical devices. We are committed to excellence in design, manufacturing, and regulatory compliance.
Position Summary
The Senior Manager of Quality Assurance will lead and manage the Quality Assurance team, ensuring the company's products meet the highest standards of quality and compliance. This role is critical to maintaining regulatory compliance, managing quality systems, and driving continuous improvement initiatives across the organization.
Key Responsibilities
- Quality Management Systems: Oversee the development, implementation, and maintenance of Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
- Regulatory Compliance: Ensure compliance with all relevant regulatory standards and guidelines, including FDA, EU MDR, and other international regulations.
- Audits and Inspections: Lead internal and external audits, including preparation, execution, and follow-up. Act as the primary point of contact for regulatory inspections.
- Product Quality: Oversee product quality assurance activities, including design control, risk management, verification and validation, and production quality control.
- Supplier Quality Management: Develop and manage the supplier quality program, including supplier qualification, audits, and performance monitoring.
- Non-Conformance and CAPA: Lead the investigation and resolution of non-conformances, customer complaints, and corrective and preventive actions (CAPA).
- Team Leadership: Manage and mentor the Quality Assurance team, fostering a culture of quality and continuous improvement. Develop and implement training programs to enhance team competencies.
- Continuous Improvement: Drive continuous improvement initiatives to enhance product quality, reduce costs, and improve operational efficiency.
- Reporting: Provide regular reports and updates to senior management on quality metrics, issues, and improvement activities.
- Collaboration: Work closely with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Operations, to ensure quality objectives are met.
Qualifications
- Education: Bachelor’s degree in Engineering. Advanced degree preferred.
- Experience: Minimum of 8-10 years of experience in Quality Assurance within the medical device industry, with at least 3-5 years in a managerial or leadership role.
- Certifications: ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification preferred.
- Regulatory Knowledge: Strong understanding of ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulations.
- Skills: Excellent leadership, communication, and problem-solving skills. Strong analytical and decision-making abilities.
- Attributes: Detail-oriented, proactive, and able to work in a fast-paced environment. Commitment to ethical standards and continuous improvement.
