Sr. Quality Engineer II

Position Title:

Sr.

Quality Engineer II Work Location:

Mansfield, MA 02048

Assignment Duration:

12

Month Note:

75% non-conformance material; Please make sure candidates are submitted with experience in EUMDR.

Position Summary:

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.

Background & Context:

This role supports processes in base business and will supervise, lead and mentor other Engineers and Technicians at The Organization.

Key Responsibilities:

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. Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. Conduct benchmarking to develop more effective methods for improving quality. Approve IQ, OQ, PQ, TMV or Software Validations. Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints Escalation of quality issues as appropriate. Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

Qualification & Experience:

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.