We are looking for a quality engineer to help us deliver our world-class digital platform that delights our customers and positively impacts the surgical landscape, empowering surgical communities worldwide. You’ll work both across the entire company and also across regions and surgical disciplines to ensure the regulatory compliance, and data strategy delivers on what’s best for the surgeon, the patient, and our business partners.
REQUIREMENTS AND RESPONSIBILITIES:
- Build out quality management system conforming to 21 CFR Part 820 & ISO13485
- Provide support for regulatory submissions worldwide, particularly in the US and EU
- Evolve the quality management system to meet Proximie’s growing needs and expanding product portfolio
- Be the voice of compliance, ensure compliant products, devices, and drive organizational awareness and education for regulatory and quality
- Provide support for complaint management, corrective and preventive actions (CAPA), audits and other applicable quality management system activities across the entire organization and across multiple product lines
- Drive document releases and updates
- LOCATION: San Francisco, California – US
- BA/BS in Biomedical Engineering or related field
- 3+ years of medical device, Medtech, and digital health experience
- Track record of delivering exceptional, compliant regulated products to market
- 3+ years experience with global data privacy strategy
- 2+ years experience building out and managing quality management systems, ISO13485, etc.
- Good communicator with the ability to align across many stakeholder groups.
- Medical device experience and knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, data privacy laws (especially GDPR, HIPAA) and cybersecurity
- Start-up and/or healthcare experience
- MS in Biomedical Engineering, Computer Science, Electrical Engineering or related technical field
- Experience with Health IT, Digital Health and/or surgical domain