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.