Senior Quality Engineer

Senior Quality Engineer Plastic Executive Recruiters, LLC Grand Rapids, MI Job Details Full-time Up to $140,000 a year 5 days ago Benefits Relocation assistance Health insurance Dental insurance 401(k) Vision insurance Qualifications Medical device validation Procedural guides ISO standards Quality control statistical data analysis Engineering

APQP ERP

systems Dimensional inspection Compliance audits & assessments Six Sigma methodology implementation Engineering process optimization Corrective and preventive actions (CAPA) Manufacturing standard operating procedures Dimensional measurements Quality assurance Bachelor's degree in engineering Bachelor's degree Quality control documentation Precision measurement in machining Performance Improvement (PI) FMEA Productivity software Quality audits Quality assurance within manufacturing Manufacturing Root cause analysis PPAP Senior level Cross-functional collaboration Manufacturing company experience Implementing lean manufacturing processes

ISO 13485

Cross-functional communication Engineering validation New product launch experience 10 years Full Job Description A growing precision manufacturing organization supporting the medical device industry is expanding its quality team and seeking a Quality Engineer to play a key role in driving process improvement, product quality, and compliance across production operations. This position is highly integrated with manufacturing, engineering, and operations, supporting both ongoing production and new product introduction within a fast-paced, high-volume environment. The organization offers a diverse range of manufacturing capabilities including CNC machining, metal stamping, wire EDM, forming, and metal injection molding (MIM), supporting full lifecycle development from prototyping through scaled production. What You'll Be Doing Provide hands-on quality engineering support directly on the manufacturing floor Analyze production and process data to identify trends, reduce downtime, and improve yield Lead root cause analysis and drive corrective and preventive actions (CAPA) for non-conforming materials Develop and maintain quality documentation including APQP, SOPs, control plans, and work instructions Execute PPAP submissions and First Article Inspection Reports (FAIR) Perform dimensional inspections using precision metrology tools including calipers, micrometers, and gauge pins Conduct Gage R&R and measurement system analysis (MSA) Support internal audits and maintain compliance with ISO 9001 and

ISO 13485

standards Partner with engineering on new product launches, process validation (IQ/OQ/PQ), and continuous improvement initiatives What We're Looking For Bachelor's degree in Engineering or related technical discipline A minimum of 10 years of quality engineering experience within a manufacturing environment Experience working within ISO 9001 and/or

ISO 13485

quality systems Strong knowledge of Lean Manufacturing, Six Sigma, SPC, FMEA, and continuous improvement tools Hands-on experience with metrology and inspection equipment Familiarity with ERP systems and Microsoft Office tools Ability to work cross-functionally and drive problem-solving initiatives on the production floor This is an opportunity to join a collaborative team focused on quality, innovation, and continuous improvement within a technically diverse manufacturing environment. This role is being advertised across several strategic markets to increase visibility. Depending on the selected candidate's location, relocation may be required and will be supported with a relocation package. Keywords Quality Engineering | Manufacturing Quality |

ISO 9001

|

ISO 13485

| APQP | PPAP | FAIR | CAPA | Lean Manufacturing | Six Sigma | SPC | FMEA | MSA | Gage R&R | Process Validation |

IQ OQ PQ

| Metrology | CNC Machining | Metal Injection Molding | Precision Manufacturing | Medical Device Manufacturing H1

Pay:

Up to $140,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Relocation assistance Vision insurance Application Question(s): Do you have at least 10 years of experience working as a Quality Engineer in a manufacturing environment? Do you have experience working within an

ISO 13485

quality system? Do you have hands-on experience with APQP, PPAP, FAIR, and CAPA processes? Have you worked in a regulated manufacturing environment such as medical device manufacturing?

Work Location:

In person