EPM Scientific are looking for a Quality Specialist – Post Market on a 2 year contract to join the Quality team. The Quality Specialist – Post Market will provide hands-on support to ensure complaints are reviewed and assessed in a timely manner. Duties include, but are not limited to, day-to-day complaint review, investigation reports, adverse event reporting, and complaints log and trend maintenance.
Our work environment is a fast-paced atmosphere, fostering excellent cross-functional collaboration. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individual who is quality driven and patient focused to join our team!
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
- Evaluates all information from a technical perspective to ensure appropriate Analysis and Investigation
- Meets minimum productivity expectations for investigating assigned complaint category
- Reviewing peer investigations to support final closures
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
- Background with firmware/hardware related complaints investigation a plus
- Attention to detail and timeliness are critical
- Excellent communication (verbal and written) and interpersonal skills required
- Demonstrated experience with MS Word, Excel, Adobe Acrobat and other commonly used software systems
- Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
- Must be able to work under minimum supervision and in a team environment.
- Must be a positive and energetic team player
- If you are interested, I would be able to get interviews booked in with the client as early as this week.
Please send over your up to date resume.
Kind regards,
Marcel
