Senior Quality Engineer

The Sr. Quality Engineer II will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The individual will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. The individual will utilize appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.

This person will support processes in base business and supervise, lead and mentor other Engineers and Technicians.

• Minimum required education and experience:
  Bachelor's degree or equivalent with 8+ years of experience, Master’s degree with 5+ years of experience, Doctoral degree with 3+ years of experience.
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Good technical understanding of manufacturing equipment and processes is required.
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position
• EUMDR Class II & III Compliance Projects
• Works in a cross-functional team to assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required remediation activities.
• Works with supplier base to identify gaps to EUMDR requirements, specifically related to Process Validation.
• Approve IQ, OQ, PQ, TMV or Software Validations.