Quality Engineer - II

Quality Engineer

• II Entegee
• 3.7 Ann Arbor, MI Job Details Contract $45
• $50 an hour 19 hours ago Benefits Commuter assistance Disability insurance Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Engineering First article inspection Dimensional measurements Bachelor's degree in engineering Packaging Process validation (IQ/OQ/PQ) FMEA Quality assurance within manufacturing Test validation method Full Job Description 12+ Months
• Contract to Direct Monday
• Friday Onsite Job Summary Seeking a Quality Engineer to support MDR remediation and manufacturing quality activities for medical device product families.

This role works cross-functionally to ensure compliance with quality systems, process controls, and regulatory requirements while supporting manufacturing and product changes. Duties Conduct FAIs and complete related documentation Develop and maintain PFMEAs, Control Plans, and risk assessments Support process validations, packaging/fit testing, and manufacturing changes Perform production floor observations and dimensional verification activities Review and approve manufacturing change orders Coordinate with engineering, manufacturing, planning, and warehouse teams Manage documentation and change records within Agile PLM Qualifications Bachelor's degree in Engineering or related field Quality engineering experience Experience with process validations and test method validations Experience creating PFMEAs, Control Plans, and risk documentation Experience performing FAIs, dimensional verification, and manufacturing/packaging change evaluations Knowledge of medical device quality systems preferred Experience with Agile PLM or similar systems preferred Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPB Pay:

$45.00

• $50.

00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance People with a criminal record are encouraged to apply

Work Location:

In person