Senior Design Quality Engineer

Do you want to join an established & small Medical Device company? This the newly created Senior Design Assurance Engineer position will give you the opportunity to lead and mentor quality members and take the reigns on all design quality activities at a leadership level. You will work within the quality team with both sustaining and new product activities in the pipeline. This position is based in NJ and will be on-site.

Main Responsibilities

• Reviewing and maintenance of risk management files, including risk analysis documentation
• Reviewing of test protocols to ensure compliance with QMS processes, with sufficient statistical justification for sampling and acceptance criteria
• Ensuring compliance of design controls per regulations and internal process requirements
• Reviewing sampling plans for adequacy by applying attribute, variable, and sequential sampling methods

Experience Required

• 7+ year experience in the Medical Devices experience, primarily in Design & Quality Engineering
• Bachelor’s degree in engineering or other technical discipline
• Experience with product development life cycle, design and development, risk management, and design/process verification/validation
• Ability to perform and review risk analysis tools (FMEAs, Hazard Traceability Matrices)
• Ability to review and perform Root Cause Analysis
• The soft skills to be the sole representative of quality in engineering meetings, being the voice of the design quality initiatives

For more information about this or other positions please contact Devon Moschella at devon.moschella@jcwgroup.com or

 646-367-2742