Ecocareers ยท 2 months ago
Design Quality Engineer
Franklin Lakes, NJ
Full-time
Onsite
Senior LevelConfidential company is seeking a Design Quality Engineer to lead and support design verification and validation activities. The role involves ensuring compliance with regulatory standards and collaborating with cross-functional teams to enhance product quality and safety.
Staffing & Recruiting
Responsibilities
Lead and support design verification and validation activities, including test method development and execution
Perform sample size selection and statistical data analysis to support design decisions and risk 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), 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
Qualification
Required
Lead and support design verification and validation activities, including test method development and execution
Perform sample size selection and statistical data analysis to support design decisions and risk 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), 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)
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase