Quality Engineer

Quality Engineer Entegee - 3.7 Ann Arbor, MI Job Details Contract $40 - $50 an hour 1 day ago Benefits Commuter assistance Disability insurance Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Content creation for technical audiences Technical writing within manufacturing Manufacturing facility Shipping & receiving Bachelor's degree in engineering Continuous improvement Productivity software Manufacturing Root cause analysis Cross-functional communication FDA regulations Full Job Description 12 Month Contract M-F Onsite Overview The Quality Engineer (QE) supports MDR remediation activities and ongoing manufacturing quality assurance for designated product families. This role is responsible for ensuring manufacturing processes, labeling, packaging, and documentation comply with internal quality standards and applicable regulatory requirements. The QE collaborates cross-functionally with Manufacturing, Planning, Warehouse Operations, Product Engineering, and Quality teams to assess risks, implement process controls, and support product and process changes required for MDR compliance and continuous improvement initiatives. Duties Conduct First Article Inspections (FAIs) and complete associated documentation and reports. Develop, maintain, and update risk management documentation including Process FMEAs (pFMEAs) and Control Plans for product families and technical files. Perform production floor observations and process tours to ensure risk assessments accurately reflect current manufacturing practices. Collaborate with Manufacturing, Quality, and Product Engineering teams to gather input for risk assessments, MDR remediation activities, and process improvements. Coordinate with product engineering teams to align on product family updates and MDR-related changes. Perform packaging evaluations and fit testing (e.g., carton dimension changes) and document results in formal reports. Review, support, and approve manufacturing change orders and engineering changes. Conduct label verification and grading activities and generate associated documentation and reports. Coordinate label printing and shipping activities with production line leads, supervisors, planning, and warehouse personnel as needed. Support product testing and evaluation activities by coordinating materials and components with warehouse operations. Maintain and manage documentation, technical files, and change records within Agile PLM. Support process validation and test method validation activities including protocol development, execution, and reporting. Ensure compliance with applicable quality systems, regulatory requirements, and internal procedures. Required Qualifications Bachelor's degree in Engineering (Quality, Mechanical, Biomedical, Industrial, or related field). Minimum of 2 years of relevant experience with a Bachelor's degree, or 1 year of relevant experience with an advanced degree. Experience in Medical Device Regulation (MDR) remediation activities highly preferred. Knowledge of medical device quality systems and manufacturing quality practices. Strong technical writing and documentation skills. Ability to work effectively in a cross-functional manufacturing environment. Proficiency with Microsoft Office applications and PLM/document management systems. Preferred Qualifications Experience working in regulated medical device manufacturing environments. Familiarity with Agile PLM or similar product lifecycle/document management systems. Knowledge of

FDA, ISO

13485, and MDR regulatory requirements. Experience with root cause analysis, CAPA, and continuous improvement methodologies. 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

GRPB Pay:

$40.00 - $50.00 per hour

Benefits:

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

Work Location:

In person