Job Type
Full-time
Description
Job Summary The
Manager of Quality Assurance is responsible for leading site-level quality operations and maintaining compliance with the Quality Management System (QMS), applicable regulatory requirements, and customer expectations. This position leads Quality Engineering and Inspection activities, oversees CAPA and nonconformance processes, supports audit readiness, monitors quality performance, and partners with Manufacturing, Engineering, Operations, and Regulatory teams to drive continuous improvement and reduce Cost of Poor Quality (CoPQ). Reports to the Director of Quality.
Responsibilities - Quality Management System: Maintain and support the site QMS in accordance with ISO 13485, 21 CFR 820, ISO 14971, customer requirements, and applicable regulatory standards. Support internal, customer, registrar, and regulatory audits.
- Quality Operations: Lead day-to-day Quality Assurance, Quality Engineering, and Inspection activities. Establish priorities, ensure adequate resources, and promote consistent execution of quality processes.
- CAPA & Nonconformance: Oversee nonconformance, CAPA, and root-cause investigations. Ensure timely completion, effectiveness, and prevention of recurring issues.
- Quality Performance: Monitor key quality metrics including First Pass Yield (FPY), Cost of Poor Quality (CoPQ), nonconformance, CAPA cycle time, and customer quality performance. Identify trends and drive corrective actions.
- Manufacturing Quality: Partner with Manufacturing and Engineering to improve process capability, reduce defects, support MRB activities, and drive continuous improvement.
- Customer Quality: Support customer complaints, quality investigations, RMAs, and corrective actions. Ensure timely and effective responses to customer quality concerns.
- Supplier Quality: Partner with Supplier Quality and Purchasing to address supplier nonconformances, incoming quality issues, and SCARs.
- NPI & Engineering Support: Provide quality support for new product introduction, design transfers, process development, validation, and process changes.
- Audit & Risk Management: Maintain site audit readiness, support Management Reviews, identify quality risks, and ensure appropriate escalation and mitigation.
- Site Team Leadership: Represent the quality function with the Site's Leadership team. Lead, coach, and develop quality team members. Establish clear expectations, performance goals, accountability, and development plans.
- Continuous Improvement: Promote Lean, Six Sigma, SPC, DOE, and data-driven problem-solving practices to improve quality and operational performance.
- Travel: Up to 10%-15% travel may be required, including travel to other Biomerics facilities, customer sites, suppliers, or training locations.
Requirements
- Bachelor's degree in Engineering, Materials Science, Plastics, Quality, or a related technical field preferred.
- Equivalent education and experience may be considered.
- 7+ years of experience in medical device manufacturing, quality assurance, quality engineering, or a related regulated industry.
- 2+ years of leadership or supervisory experience preferred.
- Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, and applicable FDA requirements.
- Experience with QMS, CAPA, nonconformance, complaint handling, risk management, and change control.
- Proficiency in root-cause analysis methods such as 5-Why, Fishbone, and 8D.
- Experience with SPC, Lean Manufacturing, Six Sigma, and continuous improvement preferred.
- Strong analytical, communication, organizational, and leadership skills.
- Ability to effectively lead cross-functional teams and drive accountability.
