Lead Quality Engineer - Medical Devices & Compliance Job at Purple Drive Technologies, Franklin Lakes, NJ

WlBBenNhLzBQNkk2UlRPOGlVR3dveDNGMXc9PQ==
  • Purple Drive Technologies
  • Franklin Lakes, NJ

Job Description

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)

Job Tags

Full time

Similar Jobs

Anera

Writing Intern Job at Anera

 ...Business Bureau, Charity Navigator and Guidestar, and is a trusted partner of the US Agency for International Development (USAID), United Nations agencies, scores of foundations and institutional donors, and thousands of private individual and family donors. Anera is an... 

christus health

Nurse Extern I - Nursing Internship Job at christus health

 ...various direct patient care activities in accordance with the Nursing Department policies and procedures. The Nurse Extern I is able to assist with the care of hospitalized patients. The Nurse Extern I may be assigned other functions in accordance with hospital/department... 

BritePros Medical Staffing

Bank Teller Supervisor Job at BritePros Medical Staffing

 ...Bank Teller Supervisor To $52K - Chicago, IL 3209 Who We Are: The Symicor Group is a boutique talent acquisition firm based...  ...for your future. You also bring the following skills and experience: High School Diploma or GED, College degree preferred.... 

City of Marietta, GA

2026 Equipment Operator Job at City of Marietta, GA

 ...Division of the Public Works Department that reports directly to the Streets Supervisor. This position is responsible for the operation heavy equipment in the repair of streets, sidewalks, drains and gutters, and street sweepers Operates construction equipment... 

EPIC PIPING, LLC

Fitter/Pipe Fabricator - Multi Positions Available Job at EPIC PIPING, LLC

 ...backgrounds extending from engineering to welding, Epic Piping provides unmatched experience servicing the chemical, power, refining, offshore, and oil & gas industries. As an equal opportunity employer, Epic Piping is committed to the development of its employees and...