Hiring: Manager, QA/RA

About Shift Labs

Shift Labs is a medical device company that believes simple innovations can save lives. We create well-designed devices for fast-growing healthcare sectors in the US and around the world globally. In practice, this means our devices can be found in hospitals and homes in the US as well as Ebola Treatment Units and refugee camps around the world. We combine great design with proven technology in order to make affordable devices that contribute to healthcare equity.

Job Summary

Our team is looking for someone to drive our medical device quality and regulatory work. We are a small, nimble company, and a successful candidate for this position will have excellent research skills, tenacity, curiosity, attention to detail, great interpersonal skills, flexibility and a sense of humor.

The Manager of Quality Assurance and Regulatory Affairs will maintain a scalable quality system compliant with applicable domestic and international medical device regulations.  This role is responsible for the content and oversight of all product submissions, including but not limited to 510(k)s and CE Technical Files. The Manager of QA/RA will also provide expertise and guidance to support day-to-day quality assurance and quality control activities for medical device design, development and manufacturing.  Since this is a small company with one product on the market and a second product about to launch, we envision this role as part-time.

Shift Labs was built by leaders new to healthcare, who were energized by skilling up in a new field. That means we’re open to hiring someone with the right mindset even if they lack specific background skills.

What the Job is Really About

Quality Assurance

  • Maintain and improve our Quality Management System and ensure the QMS remains compliant with all relevant regulatory requirements.

  • Support engineering teams during product design and development.

  • Interact with production facilities and suppliers to ensure continued quality standards during manufacturing. We manufacture our products with a partner in Washington state.

  • Measure and report the health of the quality system at regular intervals to help the rest of the team improve.

  • Provide support for investigation, root cause, and necessary actions as a result of customer feedback, complaints or audits.

Regulatory Affairs

  • Maintain company FDA and CE registration and device listings.

  • Facilitate internal and all third party audits (FDA, Notified Body, customer, etc.).

  • Research, outline and execute regulatory strategies for new products.

  • Oversee the creation and management of all product submissions, Technical Files, device applications through the regulatory process.

  • Ensure all product labeling is in compliance with regulations and approved/cleared label claims.

  • Work closely with Engineering, Manufacturing, and Sales Teams to plan and execute new product launches

Preferred Requirements

  1. Bachelor's degree (B.S., B.A., B.S.E.,  etc.), or equivalent experience.

  2. Not afraid of data, with an ability to analyze data using different methods (qualitative and/or quantitative).

  3. A willingness to learn and stay up-to-date on a variety of medical device regulations and standards. An appreciation for the jargon and alphabet soup of standards, including but not limited to: 21 CFR 820, 21 CFR 803, 21 CFR 801, ISO 13485, ISO 14971, MDD and MDSAP.

  4. Current knowledge of FDA and international quality system regulations a plus. 

  5. Adaptability and appreciation of cross-disciplinary expertise.

  6. Either experience with or curiosity about product development and applicable design control requirements.

  7. A strong understanding of risk management including what it means to manage risk.

  8. Certified quality auditor (CQA), Certified Quality Engineer (CQE), Regulatory Affairs Certification (RAC) recommended but not required. 

Core Skills

  1. Excellent written and verbal communication skills.

  2. Proficiency with Microsoft Office including Word, Excel, PowerPoint, and Outlook

  3. A positive, solution-oriented attitude that motivates and inspires others.

  4. Experience with project management.

  5. Ability to conduct self-directed research.