Quality Systems Governance Specialist
hace 3 semanas
A Quality Systems Supervisor at Medtronic is responsible for ensuring the development and maintenance of quality programs, systems, processes, and procedures that meet internal and external standards.
The ideal candidate will have expertise in interpreting policies, regulatory, and governmental regulations, and internal regulations to assure compliance.
- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures.
- Provides expertise and guidance in interpreting policies, regulatory, and governmental regulations.
- Works directly with operating entities to provide process analyses oversight.
- Liaises with auditing groups and inspectors during audits.
- Prepares reports and documentation, and provides to stakeholders.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
Requirements:
Industrial Engineer or Completed Professional Career
2 years minimum of experience as a Quality Engineer in the manufacturing environment, preferably of medical products
Bilingual: 70%
Preferred Qualifications:
Problem resolution and use of quality tools:
(Pareto, Brainstorming, Histograms, Process Capability, GR&R, Process Mapping, FMEA)
Knowledge of cGMP, ISO 13485; 2016 & QSR
Computer packages (Excel, Word, Power Point)
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