Requirements
- Three (3) or more years of hands on experience performing Quality System support activities in a U.S. FDA regulated environment.
- Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807).
- Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations).
- Excellent leadership, communication, collaboration, team work and interpersonal skills.
- Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
- Excellent computer and internet search skills.
- Strong ability to multi-task and to meet business deadlines.
- Excellent organizational skills with an ability to think proactively and prioritize work.
Nice to Have
- Bachelor Degree highly preferred.
Benefits
- 8% Bonus opportunity
- Medical
- Dental
- Vision
- Life Insurance
- 401k
- Paid Time Off
Additional Information
- Travel: Occasional (up to 25%) travel may be required based on business need.
- Physical requirements: The ability to sit up 75-100% of applicable work time.
- Physical requirements: The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.
- Physical requirements: The ability to stand, talk, and hear for 75% of applicable work time.
- Physical requirements: The ability to lift and carry up to ten pounds up to 20% of applicable work time.
- Physical requirements: Close Vision: The ability to see clearly at twenty inches or less.
- In the event that COVID-19 vaccine mandates become effective, the Company will require that the successful candidate be fully vaccinated against COVID-19, absent an accommodation.
- For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent an accommodation.
