Quality Engineer - Medical Devices

Quality Engineer Sault Ste. Marie, MI | Full-Time | On-Site A Michigan-based manufacturer of orthopedic surgical instruments is hiring a Quality Engineer to support plant operations in Sault Ste. Marie. The company produces precision instruments used in orthopedic procedures, including hand-held and robotic-assisted surgical tools designed for soft tissue and bone applications. This is a plant-level role embedded directly in manufacturing, offering broad exposure to quality systems, supplier management, and continuous improvement in a regulated medical device environment. Schedule Monday through Friday, standard day shift. Compensation $80,000 - $95,000 Per Year What You'll Do The Quality Engineer supports manufacturing operations across the full product lifecycle, from new product introduction through sustained production. Day-to-day work involves developing and maintaining inspection plans, participating in Material Review Board reviews, and leading corrective and preventive action (CAPA) processes when nonconformances arise. A significant portion of the role is focused on process control and validation. You will develop and maintain Process Failure Mode and Effects Analysis (PFMEA) documentation and Control Plans, support process and product validation activities, and build out Statistical Process Control (SPC) programs. Process capability studies and Measurement System Analysis, including Gage R&R, are core responsibilities. You will also work directly with inspection equipment, including programming and supporting the inspection tools used on the floor. Work instruction development and employee training on quality procedures and inspection standards are part of the role. Supplier engagement is active, including conducting vendor audits and collaborating with suppliers to standardize inspection processes. The position also supports both internal and external customer audits. Required Qualifications Bachelor's degree in Engineering or a related technical discipline Experience using precision measuring equipment in a manufacturing environment Familiarity with CAPA, PFMEA, Control Plans, and inspection planning Working knowledge of quality management systems in a regulated manufacturing setting Ability to work cross-functionally with manufacturing, engineering, suppliers, and customers Preferred Qualifications 3 or more years of quality engineering experience in medical device or precision manufacturing Experience with Statistical Process Control (SPC) and process capability analysis Gage R&R and Measurement System Analysis experience Six Sigma certification or applied Six Sigma project experience Lean Manufacturing knowledge and involvement in continuous improvement initiatives Familiarity with

FDA 21 CFR

Part 820 or

ISO 13485

quality system requirements Experience supporting supplier audits and external customer audits Compensation and Benefits Competitive base salary Medical, dental, and vision insurance 401(k) with employer match Paid time off and paid holidays To apply , submit your resume through Indeed. Qualified candidates will be contacted directly.