Sr. Quality Engineer II - Katalyst Healthcares & Life Sciences

• d ownership for material identification, material segregation, classification of defect types including the successful application of thAccountability anese techniques on a day-to-day basis in manufacturing.

• Analyse/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.

• 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.

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

• 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.