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 company wide CAPA and compliance program.

• 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.