Medical Device Quality Engineer — Manufacturing Excellence

City of Lincoln; Kentwood (MI); On-site; USD 80,000 - 110,000; Full time

Job summary

Unknown company is seeking a Manufacturing Quality Engineer to drive root cause analysis and quality improvements in medical parts inspection, ensuring precision and compliance.

You will lead corrective and preventive actions, apply GD&T and metrology, develop control and sampling plans, and support PPAP/APQP for new product launches. Strong writing, interpersonal skills, and knowledge of ISO 9001, ISO 13485, and FDA 21 CFR 820 are required.

Qualifications

• Minimum Bachelor’s Degree in an Engineering or Science discipline.
• Experience with ISO 9001 and ISO 13485 standards and FDA 21 CFR part 820 preferred.
• Ability to lead corrective and preventive actions and drive data‑driven improvements.

Responsibilities

• Leads corrective and preventive actions and verifies effectiveness.
• Applies metrology and GD&T to develop inspection methods.
• Develops control plans and sampling methods based on process data.
• Supports APQP/PPAP processes for new product launches.
• Conducts internal audits and supplier qualification activities.

Skills

Interpersonal skills

Written communication

Quality control knowledge

Fast-paced environment

Education

Bachelor's degree

Job description

Unknown company is seeking a Manufacturing Quality Engineer to drive root cause analysis and quality improvements in medical parts inspection, ensuring precision and compliance.

You will lead corrective and preventive actions, apply GD&T and metrology, develop control and sampling plans, and support PPAP/APQP for new product launches. Strong writing, interpersonal skills, and knowledge of ISO 9001, ISO 13485, and FDA 21 CFR 820 are required.