Quality Engineering Manager

We are a team of adaptable, customer‑focused professionals who value integrity, accountability, collaboration, and servant leadership. Our employees take ownership of their work and are driven to deliver high‑quality, life‑enhancing medical technologies.

The Quality Engineering Manager is a key member of the site leadership team and serves as the primary Quality leader and Management Representative. This role is responsible for overseeing and continuously improving the Quality Management System (QMS) within an FDA and ISO 13485 regulated medical device manufacturing environment. The position requires strong leadership, technical expertise, and the ability to partner effectively across operations, corporate functions, customers, and suppliers.

This role leads a quality organization of 20+ associates, including 7 direct reports, across multiple manufacturing buildings.

Key Responsibilities

• Champion company values including customer focus, integrity, accountability, teamwork, agility, and servant leadership
• Provide strategic direction for all Quality Assurance and Regulatory programs to ensure compliance with FDA regulations, ISO 13485 standards, and customer requirements
• Design, implement, and sustain quality system processes including:
• Document control
• Training systems
• Corrective and Preventive Action (CAPA)
• Nonconformance and discrepancy management
• Product release
• Review, approve, and maintain quality system documentation and procedures
• Partner with site leadership and corporate quality teams to drive process adherence and performance against key quality metrics
• Lead quality engineering and inspection support teams to improve efficiency, identify root causes, and implement sustainable solutions
• Serve as the primary quality interface for customers and suppliers, addressing quality concerns and driving satisfaction
• Recruit, develop, coach, and mentor quality team members; support performance management and professional growth
• Plan and lead internal and external audits, including regulatory, customer, and third‑party audits
• Ensure effective execution of corrective actions resulting from audits, customer feedback, and quality events
• Communicate and implement changes related to revisions, validations, and evolving quality or regulatory requirements
• Maintain a robust and compliant Quality Management System aligned with applicable regulatory and customer expectations
• Perform additional duties as assigned

Qualifications

• Bachelor’s degree in Engineering, Quality, or a related technical discipline
• Minimum of 5 years of experience in Quality Assurance and Regulatory Affairs within medical device manufacturing or another regulated industry (e.g., automotive or aerospace)
• Required:
  
  Experience with precision machining and/or metal processing
• Strong working knowledge of ISO 13485, FDA regulations, and CAPA processes
• Proven experience leading internal and external audits and sustaining a compliant QMS
• Knowledge of CMM programming and inspection systems
• Ability to read and interpret engineering drawings and technical blueprints
• Proficiency with Microsoft 365 applications (Word, Excel, PowerPoint)
• Required:
  
  Experience using Oracle and IQS quality systems
• Preferred:
  User‑level experience with Power BI
• Experience using statistical analysis tools such as Minitab
• Strong written and verbal communication skills with the ability to influence at all organizational levels
• Structured problem‑solving capabilities in complex, regulated environments
• Demonstrated leadership experience, including team development, coaching, mentoring, and performance management

Physical Requirements

• Regular performance of light administrative tasks
• Occasional lifting of up to 20 lbs. and carrying up to 10 lbs.
• Ability to perform minimal bending, standing, pushing/pulling, or climbing as required
• Manual dexterity to handle small components and tools
• Visual acuity to evaluate fine detail, including use of microscopes or similar inspection equipment

Compensation

• Base salary range: $120,000 – $140,000 per year
• Actual compensation will be determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law
• This role may be eligible for…