Quality Engineer - W2 Only

Quality Engineer -  Franklin Lakes, NJ/ Onsite - 6 Months

Please find below job description and let me know if you are interested

Job Title: Quality Engineer
Location:  Franklin Lakes, NJ/ Onsite
Duration: 6 months
Rate: $60/hr on w2

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)

Thanks and Regards,
Rahela Banu | IT Recruiter

ASCII Group, LLC
| Direct #
38345 W 10 Mile Rd, Suite 365, Farmington, MI 48335
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