Overview
Senior Quality Systems Specialist Jobs in Gilbert, USA at Jobtailor
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.
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.
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Title: Senior Quality Systems Specialist
Company: Jobtailor
Location: Gilbert, USA
Category:
