Senior Quality Systems Specialist

Responsibilities Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements. Provides Corrective and Preventive CAPA oversight and guidance. Develops employee communication and training programs that focus on the elements of a companywide CAPA and compliance program. Requirements Requires a Bachelor's degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Experience working with non-conformances, corrective and preventive actions. Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques. Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques. Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight. Experience in medical device, pharmaceutical and/or a comparable regulated environment. Strong analytical, process improvement, critical thinking and decision-making skills. Ability to educate people in the CAPA program. CAPA documentation systems experience (e.g. Trackwise , PQM). Influence management skills; ability to work constructively across all functions of the organization as well as external customers. Project management skills. Experience reviewing technical documentation. Strong written and verbal communication skills. Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. #J-18808-Ljbffr