Quality Engineer II

About the Client

We are partnering with a well‑established, vertically integrated medical device manufacturer supporting leading global OEMs with precision metal components and assemblies. Operating within a growing med‑tech platform, the organization is known for its advanced manufacturing capabilities and strong quality culture across highly regulated markets, including robotic‑assisted surgery, orthopedics, surgical instruments, and dental.

The company offers a collaborative, performance‑driven environment where cross‑functional teams bring innovative medical products from concept through full‑scale production, directly contributing to improved patient outcomes.

About the Opportunity

The Quality Engineer is a senior technical role focused on measurement science, quality systems, and data‑driven process control. The position leads the development and validation of advanced measurement methods and serves as the Engineering Change Coordinator for approved measurement systems, working closely with Engineering, Quality, Design, and Production teams to ensure compliance and documentation accuracy.

Key Responsibilities

• Support and prepare PPAP submissions (all levels), including control plans, PFMEAs, MSA, capability studies, and dimensional results, ensuring timely customer approval.
• Participate in APQP activities for new product introductions, ensuring quality is designed into processes from the outset.
• Apply structured problem‑solving methodologies (8D, DMAIC, Fishbone, 5‑Why) to investigate nonconformances and support CAPA activities.
• Develop, review, and maintain Control Plans, PFMEAs, Work Instructions, and Methods of Inspection.
• Conduct process capability and SPC analysis (Cp, Cpk) using statistical tools such as Minitab to support continuous improvement initiatives.
• Manage nonconforming material, dispositions, and supplier corrective actions.
• Collaborate cross‑functionally to reduce scrap, rework, and quality escapes.
• Support First Article Inspections (FAI) and customer‑specific quality requirements.
• Utilize advanced metrology equipment, including CMMs, vision systems, and other inspection technologies, to validate dimensional compliance.
• Analyze inspection and quality data, perform MSAs, and drive data‑based decision‑making.
• Maintain quality management system documentation in accordance with applicable standards and customer requirements.
• Provide technical guidance and support to quality technicians and manufacturing personnel.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related technical discipline preferred; equivalent experience considered.
• Minimum 3–5 years of quality engineering experience in a precision manufacturing environment.
• Demonstrated expertise in PPAP, APQP, PFMEA, Control Plans, MSA, and SPC.
• Strong proficiency in GD&T per ASME Y14.5.
• Experience using Minitab or equivalent statistical software.
• Familiarity with ISO 13485, AS9100, IATF 16949, or similar quality management standards.
• Ability to read and interpret engineering drawings and technical specifications.
• CMM operation and/or programming experience (Calypso or similar) is a strong plus.
• Strong written and verbal communication skills, with the ability to present technical information to cross‑functional teams and customers.
• Six Sigma Green Belt certification preferred.

Why Consider This Role

• Opportunity to work on high‑precision, regulated medical products
• Strong cross‑functional collaboration with engineering and manufacturing leadership
• Meaningful impact on product quality, measurement strategy, and new product introductions
• Stable, growth‑oriented organization with a focus on technical excellence and continuous improvement