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Quality Assurance Compliance Specialist
3 months ago
EPM are looking for two Quality Assurance Specialists with extensive experience in compliance responsibilities. The specialist in question will be expected to be On-Site 5 days a week, this would be a non-negotiable The work would involve experience working with systems such as Trackwise, Veeva or QMS.
Duties and Responsibilities:
- Investigates complaints to determine complaint cause, completes Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.
- Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
Skills and Knowledge:
- Bachelor’s Degree
- Minimum of 2 years of experience in Quality Assurance with complaint processing role.
- Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
- Must demonstrate the ability to investigate complaints with minimal guidance.
- Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues
- Understand basic principles of good technical writing skills
- Excellent communication (verbal and written) and interpersonal skills required
- Deep Knowledge of product quality systems Trackwise, Veeva e.g.
- Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
- Deep knowledge of Quality Systems (CAPA/non-conformances/SCARS)
Please send over your up to date resume and any relevant references
Kind regards,
Marcel
