- CAPA Experience (ownership or CAPA specialist).
- Organizational skills – manage a large # of tasks, keeps them progressing and completing on time.
- Collaborative – able to work with owners to help them make the best documentation possible.
- Handle the system administration of the Medtronic CAPA Management System (TrackWise).
- Organize and conduct CAPA Board meetings.
- Ensure and aid CAPA owners in the creation of compliant CAPA documentation.
- Aid CAPA Owners by critically reviewing Investigation Plans, Root Causes, Action Plans, and Effectiveness Plans.
- Aid CAPA board members by providing insights regarding the CAPAs and how the corrective actions will impact the production facility.
- Ensure on-time progression of CAPA activities to the specified due dates.
- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Coordinates legal requests in support of government investigations or litigations.
- 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.
- Prior CAPA Owner or CAPA Specialist
- Investigation and root cause analysis skills
- Technical writing knowledge
- Organization and Communication skills
- Process Validation and Computer software validation knowledge
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Description
Sr. Quality Systems Specialist (Contract through the end of August 2026// Minneapolis, MN):
HM's Top Needs:
Primary Responsibilities:
Additional Duties:
Must Have:
Nice To Have:
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Health System Specialist
Only for registered members Minneapolis
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Sr. IT System Specialist
Only for registered members Minneapolis
-
Health System Specialist
Only for registered members Minneapolis, MN
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Power Systems Specialist
Only for registered members Minneapolis
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Health System Specialist
Only for registered members Minneapolis
-
Quality Systems Specialist
Full time Only for registered members Minneapolis
-
Power Systems Specialist
Only for registered members Minneapolis, MN
-
Sr. IT System Specialist
Only for registered members Minneapolis, MN
-
Quality Systems Specialist
Only for registered members Minneapolis
-
Electromechanical Systems Specialist
Only for registered members Minneapolis, MN
-
Senior Quality Systems Specialist
Only for registered members Minneapolis
-
IS Systems Support Specialist I
Only for registered members Minneapolis, Minnesota, United States
-
Intern - Engineered Systems Specialist
Only for registered members Minneapolis
-
Senior Quality Systems Specialist
Only for registered members Minneapolis
-
Senior Quality Systems Specialist
Only for registered members Minneapolis, MN
-
Management Information Systems Specialist
Only for registered members Minneapolis
-
BAS Systems Specialist II
Only for registered members Minneapolis, Minnesota · $. - $. hourly
-
Intern - Engineered Systems Specialist
Only for registered members Minneapolis, MN
-
Management Information Systems Specialist
Only for registered members Minneapolis, MN
-
Senior Quality Systems Specialist
Full time Only for registered members Minneapolis
