Medical Device Quality Engineer – ISO 13485, PPAP & Welding

DISHER Corp.; Portage (MI); On-site; USD 70,000 - 95,000; Full time

Job summary

DISHER Corp. is seeking an experienced Quality Engineer for an onsite, 2-year project in Portage, MI. The role will support production line and equipment validation, change control, reviews, qualifications, and PPAP, with emphasis on welding quality workstreams.

A medical device quality background and ISO 13485 familiarity are required. Ideal candidates hold a related engineering degree and have hands-on experience in welding quality and PPAP processes, contributing to robust quality assurance

Qualifications

• Bachelor's degree in Quality Engineering, Mechanical Engineering, industrial Engineering, or related Engineering degree.
• Experience in ISO 13485 and Medical Device quality standards.
• Prior welding quality experience.
• Medical device experience is required.

Responsibilities

• Support validation, change control, validation reviews, qualifications, and PPAP.
• Support welding workstream.

Skills

Quality engineering

ISO 13485 awareness

Medical device quality

Welding quality

PPAP knowledge

Education

Bachelor's degree in Quality Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Industrial Engineering

Job description

DISHER Corp. is seeking an experienced Quality Engineer for an onsite, 2-year project in Portage, MI. The role will support production line and equipment validation, change control, reviews, qualifications, and PPAP, with emphasis on welding quality workstreams.

A medical device quality background and ISO 13485 familiarity are required. Ideal candidates hold a related engineering degree and have hands-on experience in welding quality and PPAP processes, contributing to robust quality assurance