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Job Summary |
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CAPA Manager
Job Code: NMD2344
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POSTED: Oct 29
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| Salary: |
Open |
Location: |
Plano, Texas |
| Employer: |
St. Jude Medical - Neuromodultion |
Type: |
Full Time - Experienced |
| Categories: |
Government, Regulatory and Code, Healthcare, Quality |
Required Education: |
4 Year Degree
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Job Description |
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CAPA Manager is responsible for creating and supporting a Quality culture across functional areas by driving compliance activities around the CAPA Program, managing continuous process/quality improvements and demonstrating compliance during internal and external audit/inspection opportunities.
Major, On-Going Responsibilities: • Coordination/management of overall CAPA process, including control of non-conformances and/or Quality Review Board activities. • Interfacing with other Managers, e.g., Engineering, Manufacturing, Clinical, QA/RA, Customer Service, etc., to ensure system issues are identified, addressed and resolved. • Drive solid root cause analysis methodology throughout process. • Ensure timely and effective CAPA relating to product and process identified issues by working closely across functions. • Completion and presentation of on-going CAPA metrics to management both at business and corporate levels. • Ensure regulatory compliance and optimization of CAPA procedures through: • Development, maintenance and improvement of documented processes • Development and implementation of employee training • Development and implementation of quality metrics to drive improvement and business results • Lead/Support key QA/RA activities, as assigned. May include, but are not limited to activities in the following areas: • CAPA investigations • Training • Internal Auditing • Data Analysis Reviews (MDR, etc.)
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Requirements |
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Education & Training: • Bachelors Degree in Engineering or related discipline • 5+ yrs relevant work experience • Minimum 3 years experience in a medical device or pharmaceutical industry. • Minimum 3 years experience with CAPA systems. • Minimum 3 years experience applying regulations (including FDA QSRs, ISO13485) • Auditor certification a plus • Familiarity with continuous improvement methodologies, including lean management • Ability to work independently in fast-paced environment with little supervision • Ability to identify root cause and creatively problem solve to achieve effective resolution • Ability to communicate effectively (both written and oral) • Team-oriented and responsive to customer needs • Strong problem solving and analytical skills • Quality focused, attentive to detail and results oriented • Ability to influence positive change effectively • Ability to build strong relationships • Proficient with software programs to facilitate data analysis work
Other Skills/Characteristics: • Attention to Detail – establishes and reinforces consistency, carelessness is not tolerated • Communicates Effectively – adjusts the message to the audience to get the point across • Decisiveness & Judgment – decisions are based on data and sound reasoning • Influencing – champion initiatives that generate organization-wide understanding and support • Problem Solving – establish resources, processes to gather information/data for problem solving or analysis
Qualified candidates should apply online via our website at http://www.sjm.com/careers and reference position NMD2344. No agencies or phone calls, please.
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