The company is a manufacturer of medical instrumentation. This position plays a very important role in the company's compliance with quality system regulations. Responsible for complaints, CAPA, Vigilance, and recall processes.
- Fully paid family medical
- Life Insurance
- Vacation, PTO, and paid holidays
- Tuition Reimbursement
- Annual bonus
- Quality & Compliance in the areas of complaint evaluation, documentation, MDR/MPR, and recall processes.
- Accurate reporting of all U.S. MDRs and Canadian MDPRs.
- Timely completion of CAPA/IMS issues.
- Support the Quality & Compliance team during external audits / inspections.
- Execution of the complaint’s evaluation process.
- Assist with the tracking & metrics required for the Management Review Process.
- Company's primary interface with the FDA and Health Canada when complaints require written reporting.
- Work closely with ASA, Q&C, and company Hotline in responding to complaints.
- A Bachelor's degree in Engineering, Science, or related discipline is required (Master's Degree is a plus).
- Minimum of 5 year’s experience in medical device quality, or quality systems.
- Strong knowledge in medical device and FDA regulations. ISO experience is a plus.
- ASQ or similar certification are a big plus.
- Up to 10% travel could be required.
- This position is not eligible for sponsorship for work authorization. Therefore, if you require sponsorship to work in the U.S., we cannot consider your application at this time.