Senior Quality Engineer

The Senior Quality Engineer is responsible for providing technical quality support to ensure customer, regulatory, and internal requirements are clearly understood and effectively implemented. This role works cross-functionally with engineering, operations, supply chain, and quality teams to support qualification, validation, and manufacturing readiness activities.

The position plays a key role in nonconformance management, supplier quality, complaint handling, and corrective and preventive action (CAPA) processes. In addition, the Senior Quality Engineer provides leadership and oversight to inspection and quality control functions to ensure consistent, high-level performance and product quality.

This role is primarily onsite at a manufacturing facility and may require occasional travel to other operational locations. Relocation assistance is not provided.

• Support and/or lead qualification activities required for manufacturing process release
• Support and/or contribute to process validation activities associated with manufacturing transfers
• Partner with manufacturing and engineering teams to drive effective nonconformance investigation and resolution
• Lead or support customer complaint handling and related CAPA activities
• Support purchasing and receiving inspection activities to ensure raw material accuracy and timeliness
• Support development and transition of manufacturing processes and controlled documentation from prototype through commercial production
• Promote adherence to Quality Management System (QMS), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP)
• Contribute to and support the internal audit program
• Participate in supplier, customer, and external audits as needed
• Lead and direct quality inspection teams to ensure high product quality and throughput
• Support production floor quality objectives, including in-line inspection, lean initiatives, and scrap reduction
• Perform other duties as assigned

• 5–8 years of experience in a regulated medical device manufacturing environment (ISO/FDA)
• Bachelor’s degree in Engineering, Science, Manufacturing, or equivalent relevant experience
• Experience with root-cause analysis, process and equipment qualification, validation, metrology, automation, and auditing
• Strong communication skills, collaborative mindset, and confidence working cross-functionally
• Proficiency with common business and quality software tools
• Ability to sit or stand for extended periods

• Experience with Class II or Class III medical devices
• Background in contract manufacturing and extrusion processes

• Competitive salary based on experience, education, and market factors
• Eligibility for an annual performance-based bonus
• Comprehensive benefits package, including medical, dental, vision, disability coverage, and supplemental insurance options
• Health savings account with employer contribution
• Paid time off, paid holidays, and sick leave
• Parental leave
• Retirement savings plan with employer match
• Opportunities for professional development and career advancement