Quality Engineer II

Karwell Technologies

Dexter, MI

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JOB DETAILS

SKILLS

Agile PLM / Oracle PLM (Product Lifecycle Management), Biomedicine, Change Control, Change Requests/Orders, Computer Systems, Healthcare Quality, Manufacturing, Manufacturing Analysis, Medical Equipment, Medical Products, Minitab, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Production Support, Quality Assurance Methodology, Quality Engineering, Risk Analysis, Risk Management, Sampling Inspection, Standard Operating Procedures (SOP), System Validation, United States Department of Energy (DOE), Validation Documentation, Validation Testing, Warehousing

LOCATION

Dexter, MI

POSTED

6 days ago

Job Description:
Quality Engineer supporting MDR remediation and manufacturing quality for medical device products, focusing on process validation, risk management, and change control.
Responsibilities :

Execute process & test method validations (IQ/OQ/PQ).
Perform First Article Inspections (FAI) and reporting.
Develop PFMEA, Control Plans, risk assessments.
Support MDR remediation activities.
Conduct packaging/fit testing and validation.
Review and approve change orders (Agile PLM).
Perform label verification and production support.
Collaborate with manufacturing, engineering, warehouse teams.

Requirements:

2+ years Quality/Validation experience.
Medical device experience preferred (MDR a plus).
Bachelor's in Engineering (Quality/Mechanical/Biomedical/Industrial).

Top Skills (Must Have):

Process Validation (IQ, OQ, PQ).
Validation lifecycle (process characterization PQ).
Test method validation & documentation.
PFMEA, Control Plans, risk documentation.
FAI, dimensional inspection, manufacturing change evaluation.
DOE experience (Minitab preferred).
CSV (Computer System Validation).
SOP development.
Inspection sampling plans.
Packaging validation.
Change control (medical devices).

About the Company

Karwell Technologies

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