Job Summary: Senior Quality Engineer responsible for ensuring quality compliance in class III medical devices, including design controls, process validation, risk management, statistical analysis, and test method validation.

Requirements:

Background in class III medical devices

Knowledge of Design Controls (21 CFR 820)

Experience with Process Validation (IQ, OQ, PQ)

Expertise in Risk Management

Proficiency in statistical analysis (MINITAB)

Experience with Test Method Validation

BSEE, ME, or Biomedical degree

Responsibilities:

Ensure compliance with design controls (21 CFR 820)

Perform process validation (IQ, OQ, PQ)

Conduct risk management activities

Perform statistical analysis using MINITAB

Validate test methods for quality assurance

Support quality assurance processes for class III medical devices

Pay: 40-54

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.

Pay Details: $40.00 to $54.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.