Regulatory

Quality Assurance and Document Control Manager

At Riva Health, you'd work with the cofounder of Siri on our mission to dramatically simplify and personalize disease management, while making our innovations accessible on devices that people already have. You'd be part of the founding group of employees helping to pave the way with best practices and processes and you'd work alongside world class biomedical engineers and machine learning experts. As a generalist, you'd also be able to specialize in key areas and help the team go from zero to launch and continue iterating through validation phases.

Details

As the Quality Assurance and Document Control Manager, you will have broad responsibility for supporting Quality Assurance, Quality Control, Compliance functions in conjunction with Riva’s Software/Technical and Clinical/Regulatory teams. The QA Manager is responsible for document control activities and will work directly with the Engineering and Product teams, helping the technical teams manage design/engineering documents in compliance with Riva’s QMS.


Responsibilities:

- Developing and maintaining a Quality System

- Develop and keep current Riva Quality Policy, Quality Manual, Standard Operating Procedures (SOPs) and quality records.

- Responsible for scheduling Management Reviews, define agenda and capture meeting minutes

- Monitoring of Design and Development activities and records for compliance to procedures

- Manage document control, ensure timely release of Quality records (DCO processing, obtaining signatures from third party reviewers)

- Ensure timely archival of hard copy final quality records

- Manage the internal quality auditing process (Scheduling, follow up)

- Scheduling and participating in vendor qualification activities

- Follow up on corrective action following Supplier Audits

- Help develop response to external audits

- Assist with risk management activities

- Responsible for interfacing with Regulatory personnel/contractors, to ensure applicable regulatory requirements are met.

- Drive continuous improvement activities through the collection and analysis of data

- Manage complaint handling (post market)

- Manage the CAPA process

- Assure integration of quality objectives into manufacturing objectives (as applicable at the third party contract vendor), while helping drive early defect identification

- Leading QC efforts in routine review and approval of Manufacturing records (as applicable at contract third party manufacturer)

- Compiling and providing statistical analysis and support quality data for management reviews


Requirements:

- BS degree in technical discipline Mechanical, Electrical, CS or Software Engineering

- 10+ years experience in the Medical Device Industry

- Strong working knowledge of ISO 13485, FDA Regulation (21 CFR), MDD

- Excellent interpersonal skills; strong written and oral communication skills

- Self-starter, comfortable in small company, strong project manager, problem solving skills

- Familiarity with software-medical devices

Whether it's working with a world class team to save lives, or taking care of yourself with great benefits and time off, we've got you covered.

Reach out to careers@rivahealth.com for more information.

Apply now
Apply now