Long Term Opportunity - Quality Engineer

Long Term Opportunity

• Quality Engineer Entegee
• 3.7 Dexter, MI Job Details Contract $55
• $60 an hour 6 hours ago Qualifications Engineering Dimensional inspection Dimensional measurements Quality control FMEA Manufacturing Document management Manufacturing company experience Engineering validation Measurement (quality control) Full Job Description The Quality Engineer supports MDR remediation and manufacturing quality activities for medical device product families.

Responsibilities include process validations, PFMEAs, Control Plans, FAIs, packaging/testing evaluations, label verification, and manufacturing change support while ensuring compliance with FDA, GMP, and MDR requirements.

Must-Have Skills:

Process Validation & Test Method Validation PFMEA, Control Plans & Risk Documentation FAI, Dimensional Inspection & Manufacturing Change Evaluation Preferred:

Medical Device or FDA-regulated manufacturing experience MDR remediation experience Agile PLM experience Packaging validation and labeling support

Key Responsibilities:

Execute FAIs and validation activities Maintain PFMEAs and Control Plans Support MDR updates and manufacturing changes Perform packaging/fit testing and label verification Collaborate with manufacturing, quality, warehouse, and engineering teams Manage documentation within

Agile PLM Education & Experience:

Bachelor's degree in Engineering or related field with 4+ years of relevant quality engineering experience in a regulated manufacturing environment. #

GRPA Pay:

$55.00

• $60.

00 per hour People with a criminal record are encouraged to apply

Work Location:

In person