Top 13 Process engineer Jobs in Traverse City, Mi

Quality Engineer
Thompson Surgical Instruments —Traverse City, MI
- Full-time
- 5 years
- Mid-level
- Office
- Health savings account
- Health insurance
Quick Apply
Manufacturing Engineer
Attalon, Inc. —Traverse City, MI
- $65,000 - $125,000 a year
- Full-time
- Customer service
- Engineering
- Mid-level
Quick Apply
Senior Process Engineer
Lear Corporation —Traverse City, MI
- 5 years
- Engineering
- US work authorization
Sr Operational Excellence Lead
Chemtrade —United States
- $150,000 - $160,000 a year
- Full-time
- Microsoft Excel
- 5 years
- Travel
- Opportunities for advancement

More jobs to discover

Find similar jobs that you might be interested in.

New Product & Mechanical Design Engineer
Holley Performance —Boyne City, MI
Three or more years of experience in mechanical design, product development, or manufacturing engineering. The New Product & Mechanical Design Engineer leads…
Quick Apply
Quality Engineer
Thompson Surgical Instruments —Traverse City, MI
Bachelor’s or equivalence in Science, Engineering, or relative technical field, min. Participate in internal and external audits (FDA inspections, ISO 13485…
Quick Apply

Show more similar jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Process Engineer
Amsted Rail —Groveport, OH
Two to seven years of experience in manufacturing, industrial engineering, process engineering, operations, or a related role.
Quick Apply
Associate Process Engineer, MS&T
Forge Biologics —Columbus, OH
The Associate Process Engineer (Drug Product) is an entry level technical contributor within Manufacturing Science and Technology (MS&T), responsible for…
Quick Apply

Show more jobs in cities nearby

I want to receive the latest job alert for process engineer in traverse city, mi

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

process engineer jobs near traverse city, mi

Quality Engineer jobs in Traverse City, MI

Manufacturing Engineer jobs in Traverse City, MI

Senior Process Engineer jobs in Northbrook, IL

Carlton Senior Living jobs in Elk Grove, CA

Senior Process Engineer jobs in Alabama

Brightview Senior Living jobs in Bel Air, MD

Process Technology jobs in Louisiana

Senior Process Engineer jobs in Reno, NV

Senior Process Engineer jobs in Lutz, FL

Water Resources Engineer jobs in Houston, TX

Quality Engineer jobs in Wixom, MI

Quality Engineer jobs in Orange County, CA

Quality Engineer jobs in Boston, MA

Engineer jobs in Michigan

Quality Engineer jobs in Virginia Beach, VA

Quality Engineer jobs in Toledo, OH

Operational Excellence Team Leader jobs in Commerce City, CO

Operational Excellence Team Leader jobs in Downers Grove, IL

Operational Excellence Team Leader jobs in Layton, UT

Operational Excellence Team Leader jobs in Newton, MA

Quality Engineer

Thompson Surgical Instruments
Traverse City, MI

Quick Apply

Job Details

Full-time

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Parental leave
Vision insurance
Professional development assistance
Life insurance
Retirement plan

Qualifications

Teamwork
Statistical Process Control
Quality audits
PPAP
FDA regulations

Full Job Description

Quality Engineer (in office – Traverse City, MI)

Thompson Retractor has an opportunity for a Product Quality Engineer. The Quality Engineer is responsible for developing, implementing, and maintaining quality systems and processes that ensure medical devices meet applicable regulatory requirements and customer expectations. This role serves as a key technical resource for inspection planning, measurement system validation, customer complaint management, and regulatory document impact assessments. The Quality Engineer will work cross-functionally with manufacturing, engineering, and regulatory affairs to uphold compliance with 21 CFR Part 820, ISO 13485:2016, and the EU Medical Device Regulation (EU MDR 2017/745).

Thompson is employee-owned and vested employees automatically receive company shares.

What you’ll do:

Develop, author, and maintain internal Quality Inspection Plans (QIPs) for machined components and assemblies, including critical-to-quality (CTQ) characteristic identification.
Lead end-to-end APQP phases for new program launches, tracking milestones to ensure compliance with customer specifications. Compile and submit complete PPAP packages- including PFMEA, Control Plans, MSA, and dimensional results—securing on-time customer sign-offs.
Collaborate with manufacturing and process engineers to ensure inspection plans reflect current production processes, drawing revisions, and design intent.
Perform initial process studies (SPC) and capability analysis to verify manufacturing process stability prior to customer submission.
Review and interpret engineering drawings, GD&T (ASME Y14.5), material specifications, and customer requirements to establish dimensional and functional acceptance criteria.
Collaborate with the CMM Programmer to capture, document, and maintain Coordinate Measuring Machine (CMM) set-up plans, including part datum alignment, fixturing requirements, probe configurations, and reference feature sequences.
Translate CMM Programmer inputs into clear, controlled set-up documentation (work instructions, setup sheets, and visual aids) that inspection personnel can consistently execute on the shop floor.
Serve as the primary Quality point of contact for the intake, processing, and closure of customer complaints in accordance with 21 CFR Part 820.198 and ISO 13485 Section 8.2.2.
Manage the end-to-end complaint lifecycle: receipt and acknowledgment, initial evaluation, complaint investigation, root cause analysis, corrective action, and formal closure.
Collaborate with the Risk Manager and Regulatory Affairs to evaluate each complaint for adverse event and MDR/Vigilance reportability; provide quality investigation findings, device history records, and risk data to support the reportability determination; ensure timely submission of Medical Device Reports (MDRs) to FDA and Vigilance Reports to Notified Bodies / Competent Authorities.
Lead and document formal impact assessments when external regulatory standards, guidance documents, or customer specifications are revised or newly issued.
Review regulatory updates for applicability to current products, processes, quality management system (QMS) procedures, and technical documentation; identify gaps and compliance risks.
Support the update or creation of quality system procedures, work instructions, forms, and technical file content to reflect regulatory changes; ensure document control compliance throughout.
Participate in internal and external audits (FDA inspections, ISO 13485 certification audits, Notified Body audits); prepare audit-ready documentation and serve as Subject Matter Expert for inspection planning, complaint management, and QMS sections.

This Might Describe You:

Bachelor’s or equivalence in Science, Engineering, or relative technical field, min. 5 + years previous quality / regulatory experience, and basic knowledge of ISO, FDA, and EU standards.
Strong working knowledge of 21 CFR Part 820 Quality System Regulation (and awareness of FDA Quality Management System Regulation transition)
Practical experience with ISO 13485:2016 QMS requirements and implementation
Understanding of EU MDR 2017/745 requirements, including UDI, PMS, Vigilance, and Technical File obligations; familiarity with adverse event reportability criteria applied in collaboration with Risk Management and Regulatory Affairs
Familiarity with MDR/Vigilance reporting criteria; ability to support reportability determinations by providing quality data and investigation findings to Risk Manager and Regulatory Affairs
Ability to read and interpret CMM set-up plans and measurement reports; experience collaborating with CMM Programmers to capture and document set-up requirements
Experience with quality tools: FMEA, 8D, Control Plans, PPAP/FAI, SPC, MSA/GR&R
Familiarity with machining processes (CNC milling, turning, grinding) and their quality characteristics

EEO/AA

Benefits:

401(k)
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Professional development assistance
Retirement plan
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

process engineer jobs in traverse city, mi

Quality Engineer

Manufacturing Engineer

Senior Process Engineer

Sr Operational Excellence Lead

More jobs to discover

Explore jobs in cities nearby

I want to receive the latest job alert for process engineer in traverse city, mi

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected