Quality Engineer III_US
Mindlance - mansfield, MA
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Monitors, inspects, and evaluates products to ensure predetermined quality standards are met. Develops and updates testing-related documentation, including test cases, plans, and flaw-reporting procedures. Bachelors Degree is required. 7+ years of experience. . SUMMARY DESCRIPTION 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 problemsolving 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. SUPERVISION RECEIVED Under direct supervision of Quality Engineering Manager SUPERVISION EXERCISED None. ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Primary responsibilities are to: • 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. JOB DESCRIPTION Job Title: EU- MDR Sr. Quality Engineer II Department: Quality Engineering Reports To: Quality Engineering Manager Location: Mansfield, MA Page 2 of 3 . • 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. It is also understood that an associate may receive special projects outside of this list DESIRED MINIMUM QUALIFICATIONS • 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. EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
Created: 2024-10-15