Quality Engineer

Quality EngineerA 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 YearWhat You'll DoThe 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 QualificationsBachelor's degree in Engineering or a related technical disciplineExperience using precision measuring equipment in a manufacturing environmentFamiliarity with CAPA, PFMEA, Control Plans, and inspection planningWorking knowledge of quality management systems in a regulated manufacturing settingAbility to work cross-functionally with manufacturing, engineering, suppliers, and customersPreferred Qualifications3 or more years of quality engineering experience in medical device or precision manufacturingExperience with Statistical Process Control (SPC) and process capability analysisGage R&R and Measurement System Analysis experienceSix Sigma certification or applied Six Sigma project experienceLean Manufacturing knowledge and involvement in continuous improvement initiativesFamiliarity with FDA 21 CFR Part 820 or ISO 13485 quality system requirementsExperience supporting supplier audits and external customer auditsCompensation and BenefitsCompetitive base salaryMedical, dental, and vision insurance401(k) with employer matchPaid time off and paid holidaysTo apply, submit your resume through Indeed. Qualified candidates will be contacted directly.