Lead Quality Systems & Validation Engineer

Job Description Is this you? Do you enjoy being the go-to Quality Engineering partner for customers and cross-functional project teams? Are you energized by building inspection plans, shaping validation strategies, and transferring NPIs into production smoothly? Do you thrive on solving problems with data—SPC, capability studies, and Gage R&R—while driving CAPA to root cause? Can you navigate supplier issues confidently, disposition nonconforming material, and keep documentation customer-ready? Are you comfortable supporting audits and ensuring compliance to Avalign procedures, customer requirements, and FDA/ISO standards? If you answered yes, you're likely the Lead Quality Systems & Validation Engineer we're looking for. What You'll Own Be the primary Quality Engineering contact for designated customers and projects. Develop robust manufacturing inspection plans and may supervise quality technicians and/or inspectors as business needs require. Lead validation planning and NPI transfer activities; advise teams on validation needs and acceptance criteria. Provide end-to-end quality support across the product lifecycle, including risk management, design changes, and complaint/NC/CAPA investigations. Champion supplier quality: manage site supplier relationships and drive resolution of supplier nonconformances. Support internal and external audits to sustain regulatory, customer, and Avalign compliance. Stand up effective corrective actions; implement quality assurance plans, process controls, and CAPA systems that meet internal and external requirements. Recommend test methods and SPC procedures to achieve target reliability levels. Conduct or direct testing and data analysis to confirm new processes meet acceptance criteria; perform capability studies and Gage R&R. Represent Quality for assigned manufacturing areas/customers to maintain compliance with Avalign procedures; customer specifications; and industry regulations, including FDA Quality System Regulation (21 CFR 820) and ISO 13485. Ensure the Material Review Board (MRB) process is consistently followed in partnership with operations and engineering. Prepare and submit documentation to customers for new launches and legacy product requests. Manage the Non-Conforming Material Reports (NCMR) system and disposition all nonconforming product. Advance product risk management; ensure planned mitigations are executed and verified. Engage in technical discussions and make informed, risk-based decisions. Identify and execute continuous improvements across the quality system and manufacturing processes. Minimum Qualifications BS in an engineering field with 5+ years in manufacturing, or equivalent education and experience. Proficiency with statistical analysis and problem-solving for product acceptance and process capability evaluation. Ability to read and interpret blueprints; strong command of GD&T and inspection methods. Knowledge of ISO 13485 and regulatory requirements under 21 CFR 820. Experience in new product introduction and/or process development within manufacturing (highly preferred). How We Work You won't feel stuck—growth and learning are part of the deal. You won't get bored—our product variety keeps the work dynamic. You won't feel like a number—we keep teams close-knit and supportive. We value self-starters who thrive in fast-moving environments. We welcome quick learners who want to deepen their understanding of manufacturing processes. We count on reliable teammates who show up when it matters. We appreciate positive, cooperative, team-first mindsets. We look for planners who can execute cross-functionally. We communicate clearly and professionally—verbally and in writing. Compensation, Benefits, and Perks Competitive compensation and benefits package Medical, dental, and vision insurance Paid vacation and 10 observed paid holidays each year Employer-funded Basic Life and AD&D Employer-funded STD and LTD Tuition reimbursement 401(k) with company match Generous employee referral bonuses Growth in a thriving, performance-based company that promotes from within Temperature-controlled environment Community involvement and giving back Additional free resources like travel assistance and EAP Core Proficiencies GD&T ISO 13485 Advanced Product Quality Planning (APQP) Advanced Inspection & Gauge Measurement Blueprint Reading