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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 64.00/hr.