Quality Engineer II

We’re partnering with a high‑performing, vertically integrated medical device manufacturer that delivers precision metal components and assemblies to leading global OEMs. As part of a growing med‑tech platform, the company is recognized for advanced manufacturing capabilities and a best‑in‑class quality culture across highly regulated markets—including robotic surgery, orthopedics, surgical instruments, and dental.

You’ll join a collaborative, performance‑driven team bringing innovative products from concept to full‑scale production—directly improving patient outcomes.

This is a senior‑level Quality Engineer role at the intersection of measurement science, quality systems, and data‑driven process control. You’ll lead the development and validation of advanced measurement methods while serving as the Engineering Change Coordinator for approved systems. The role partners closely with Engineering, Quality, Design, and Production to ensure compliance, accuracy, and continuous improvement.

• Own PPAP submissions (all levels), including control plans, PFMEAs, MSA, capability studies, and dimensional results—driving timely customer approvals
• Lead APQP activities to ensure quality is built into new products from day one
• Solve complex quality issues using structured methodologies (8D, DMAIC, 5‑Why, Fishbone) and support CAPA execution
• Develop and maintain Control Plans, PFMEAs, Work Instructions, and inspection methods
• Drive process capability and SPC analysis (Cp, Cpk) using tools like Minitab
• Manage nonconforming material, dispositions, and supplier corrective actions
• Partner cross‑functionally to reduce scrap, rework, and quality escapes
• Support First Article Inspections (FAI) and customer‑specific requirements
• Utilize advanced metrology tools (CMM, vision systems, etc.) to ensure dimensional compliance
• Perform MSAs and analyze quality data to guide decision‑making
• Maintain QMS documentation in alignment with ISO and customer standards
• Mentor and support quality technicians and manufacturing teams

• Bachelor’s in Mechanical, Manufacturing, or related field (or equivalent experience)
• 3–5+ years in quality engineering within precision manufacturing
• Deep expertise in PPAP, APQP, PFMEA, Control Plans, MSA, and SPC
• Strong GD&T knowledge (ASME Y14.5)
• Proficiency with statistical tools (Minitab or equivalent)
• Experience with ISO 13485, AS9100, IATF 16949, or similar standards
• Ability to interpret complex drawings and technical specs
• CMM experience (Calypso preferred) is a strong plus
• Strong communicator with the ability to influence cross‑functional teams

• Partner directly with engineering and manufacturing leadership
• Make a tangible impact on product quality and process performance
• Join a stable, growth‑focused organization committed to technical excellence