Quality Assurance Coordinator
2 weeks ago
This position supports the FCA Global Region Center Led organization with day-to-day operational tasks. The Quality Assurance Coordinator will act as a liaison for stakeholders involved in FCA activities, working closely to develop processes and ensure regulatory compliance.
Responsibilities
- Ensure personal understanding of quality policy/system items and follow work/quality procedures for quality system compliance.
- Provide guidance to regions on process handling and ensure alignment with QA SSC FCA specialist.
- Manage follow-ups to obtain missing information and close requests from OU according to consignee list.
- Manage SAP data to confirm information and support conciliation process.
- Execute consolidation of actions evidence, including customer letters, notifications, and product affected conciliation.
- Resolve issues to complete daily work, provide analytical support for key metrics, and operational reports.
- Closely monitor recall data entry accuracy, quality, and timelines, reporting to senior and corporate management.
- Train FCA process as needed and be a change agent for the organization, identifying and implementing improvements.
- Operate within compliant quality system environments and foster cross-functional partnerships.
Requirements
Requirements include a bachelor's degree in life science or related degree, fluent English proficiency, and 3-6 years of quality role experience.
Preferred Qualifications
- Previous experience supporting quality system audits.
- Strong technical writing and documentation review skills.
- Strong critical thinking and analytical skills.
- Independent compliance decision maker.
- Good understanding of Medical Device Regulations and the Food and Drugs Acts.
- Working knowledge of ISO 13485 and Medtronic policies and procedures.
Good understanding international regulations for Medical Devices and Drugs regarding PMV/Mandatory Medical Devices Problem Reporting, Adverse Events reporting, and Recalls.
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