Principal Supplier Quality and CAPA Engineer

Job Description

Job Description

Imagine this scenario: a high-visibility product is set to launch next quarter. You’re aligning validation protocols, confirming capability indices meet targets, and fine-tuning inspection plans. Midweek, a supplier nonconformance surfaces. You lead the MRB review, contain the issue, disposition material, and drive a data-backed CAPA to root cause—all while preparing customer documentation for the launch. If orchestrating moments like these is your sweet spot, read on.

Your Mission

• Be the principal Quality Engineering representative for assigned customers and manufacturing areas, translating requirements into actionable quality plans.
• Provide direction on inspection planning and may supervise quality technicians and/or inspectors as the operation requires.
• Lead validation strategy and NPI transfers; advise on validation requirements, acceptance criteria, and documentation rigor.
• Support quality throughout the product lifecycle—including risk management, design changes, and complaint/NC/CAPA investigations.
• Own supplier quality at the site: resolve supplier nonconformances and strengthen incoming controls.
• Support internal and external audits to uphold regulatory, customer, and Avalign compliance.
• Drive effective corrective action plans; implement quality assurance plans, process controls, and CAPA systems that meet or surpass standards.
• Recommend appropriate test methods and SPC procedures to achieve product reliability targets.
• Plan and/or conduct testing and analytics to prove process acceptance; execute capability studies and Gage R&R assessments.
• Ensure adherence to Avalign procedures, customer requirements, and industry regulations, including FDA Quality System Regulation (21 CFR 820) and ISO 13485.
• Reinforce MRB discipline with operations and engineering to ensure consistent, timely decisions.
• Prepare and deliver documentation to customers for new product launches and legacy product requests.
• Administer the Non-Conforming Material Reports (NCMR) system and disposition all nonconforming product.
• Advance product risk management activities and verify execution of defined mitigations.
• Contribute to technical reviews and make sound, risk-based decisions.
• Champion continuous improvement in the quality management system and manufacturing processes.

Qualifications

• BS in an engineering discipline plus 5+ years of manufacturing experience, or an equivalent blend of education and experience.
• Expertise in statistical analysis and structured problem-solving for product acceptance and process capability evaluation.
• Ability to interpret engineering drawings; strong command of GD&T and inspection techniques.
• Solid understanding of ISO 13485 and 21 CFR 820 requirements.
• Hands-on experience with NPI and/or process development in a manufacturing setting (highly preferred).

How You Work

• Self-starter who excels in a fast-paced environment.
• Fast learner seeking deeper mastery of manufacturing processes.
• Dependable and present when the team needs you most.
• Positive, cooperative, and team-oriented approach to assignments.
• Planner who can execute across functions and teams.
• Clear, concise communicator—written and verbal.

What You Can Skip Here

• Feeling stuck—advancement and learning opportunities are real.
• Repetition—our diverse product portfolio keeps work varied.
• Anonymity—our teams are close-knit and supportive.

Compensation & Benefits

• Competitive pay and full benefits package
• Comprehensive medical, dental, and vision
• Paid vacation plus 10 observed paid holidays annually
• Employer-funded Basic Life and AD&D
• Employer-funded STD and LTD
• Tuition reimbursement
• 401(k) with company match
• Generous employee referral bonus program
• Career advancement in a thriving, performance-driven company that promotes from within
• Temperature-controlled work environment
• Community involvement and giving back
• Additional free resources, including travel assistance and EAP

Technical Proficiencies

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