Job Description

Overview:

Role: Lead Quality Engineer - Medical Devices & Compliance

Location: Franklin Lakes, NJ

Duration: 6 months

Quality Engineer

Exp 6-8 yrs

• Key Responsibilities:

• Lead and support design verification and validation activities, including test method development

o and execution.

• Perform sample size selection and statistical data analysis to support design decisions and risk

o assessments.

• Conduct process capability studies and support design transfer to manufacturing.

• Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards.

• Collaborate with cross-functional teams including R&D, Regulatory, and Manufacturing.

• Review and approve design documentation including Design History Files (DHF),

o risk management files and test protocols.

• Provide technical guidance and mentorship to junior QEs offshore.

• Support CAPA investigations related to design issues and contribute to continuous

• improvement initiatives

• Certified Quality Engineer (CQE) or equivalent certification.

• Experience with software tools such as Minitab, JMP, or similar statistical analysis platforms.

• Familiarity with risk management standards (ISO 14971) and usability engineering (IEC 62366).

• Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part 820)

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