I’m looking for a Quality Engineer around the Bedford, MA area, who would want to be a part of bringing a ground-breaking innovation within the spinal surgery field to the market. By working on the production of the product you will be creating a medical device that combines traditional spinal surgery with Augmented Reality technology, providing surgeons with the ability to perform surgeries with more precision, resulting in faster recoveries and less time in hospitals for patients.
- Promote Quality System usage to avoid product field actions or major non-compliance in external audits.
- Participate in ISO 13485 audits and assist in FDA and other regulatory inspections
- Ensure non- conforming equipment, suppliers, manufacturing activities are noted and addressed to ensure product safety and effectiveness.
- Ensure participation in the CAPA management across the full product life cycle inclusive of involvement in the complaints process.
- Cross-functional support
- Candidate must have a B.A or B.S. in relevant technical field
- At least 1-3 years’ experience Medical Device field is preferred
- QSR Part 820 and ISO 13485 experience preferred
- Excellent organizational, time management, and attention to detail skills
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
To apply for this job please visit catalystcareers.com.