Senior Quality Assurance Engineer

4 days ago

Mansfield, Ohio, United States Mindlance Full time
Job Title: EU-MDR Sr. Quality Engineer II

At Mindlance, we are seeking a highly skilled and experienced EU-MDR Sr. Quality Engineer II to join our Quality Engineering team. This role will be responsible for utilizing Quality Engineering tools and practices to ensure the effective and efficient development, transfer, and maintenance of products and processes throughout the product lifecycle.

Key Responsibilities:
  • Assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required remediation activities.
  • Work with the 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 and 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.
Requirements:
  • 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.
  • 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.

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

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