Senior Manufacturing Quality Assurance Engineer (Medical Devices)

Picture your day: you start by reviewing capability study results from an overnight run, step into a stand-up with operations to align on Material Review Board (MRB) decisions, partner with engineering on validation for a new product introduction (NPI), and close the afternoon resolving a supplier nonconformance while preparing documentation for a customer launch. If that rhythm sounds energizing, you’ll feel at home here.

How You’ll Make an Impact

• Serve as the primary Quality Engineering interface for assigned customers and projects, ensuring their expectations are translated into robust quality plans.
• Provide leadership in developing manufacturing inspection strategies and control plans; may supervise quality technicians and/or inspectors at the facility as needed.
• Guide validation planning and NPI transfer activities; help teams determine validation scope, acceptance criteria, and documentation.
• Deliver lifecycle quality support, from design changes and risk management to nonconformance, complaint, and CAPA investigations.
• Act as the site’s quality lead for supplier management, driving resolution of supplier nonconformances and strengthening incoming quality.
• Support internal and external audits to maintain regulatory, customer, and Avalign compliance.
• Establish effective corrective actions; lead implementation of quality assurance plans, process controls, and CAPA systems that meet or exceed internal and external requirements.
• Recommend test methods and statistical process controls to achieve required reliability and consistency.
• Conduct or direct testing and data analysis to verify new processes meet acceptance criteria, including capability studies and Gage R&R.
• Represent Quality for assigned manufacturing areas/customers, ensuring adherence to Avalign procedures, customer requirements, and industry regulations, including FDA Quality System Regulation (21 CFR 820) and ISO 13485.
• Partner with operations and engineering to ensure strict adherence to the MRB process.
• Submit documentation to customers for new product launches and for legacy product information requests.
• Own the Non-Conforming Material Reports (NCMR) system and disposition all nonconforming product.
• Advance product risk management activities and ensure mitigations are implemented and effective.
• Participate in technical discussions and make sound, risk-based decisions.
• Identify and drive improvements in the quality system and manufacturing processes to fuel continuous improvement.

What You’ll Need to Succeed

• BS in an engineering discipline and at least 5 years of manufacturing experience, or an equivalent combination of education and experience.
• Fluency in statistical analysis and problem-solving to determine product acceptance and assess process capability.
• Ability to read and interpret engineering drawings; strong knowledge of GD&T and inspection methodologies.
• Working knowledge of ISO 13485 and regulatory requirements under 21 CFR 820.
• Demonstrated experience with new product introduction and/or process development in a manufacturing environment (highly preferred).

Who Thrives Here

• A self-starter who enjoys a fast-paced setting.
• A quick learner eager to deepen expertise in manufacturing processes.
• Reliable, accountable, and present when it counts most.
• Collaborative teammate with a positive, open approach to assignments.
• Capable of planning and executing cross-functional work.
• Clear, effective communicator—written and verbal.

What You Won’t Find Here

• Feeling stuck—we provide real opportunities to learn and advance.
• Monotony—our product mix is diverse, so no two days feel the same.
• Being just a number—we’re a close-knit group that looks out for one another.

Rewards & Benefits

• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer-funded Basic Life and AD&D insurance
• Employer-funded STD and LTD insurance
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• Career growth in a thriving, performance-based company that promotes from within
• Temperature-controlled work environment
• Community involvement and giving back
• Additional free resources such as travel assistance and EAP

Your Toolkit

• GD&T
• ISO 13485
• Advanced Product Quality Planning (APQP)
• Advanced Inspection & Gauge Measurement
• Blueprint Reading