Founded in 2020 and based in Silicon Valley, Empo Health® is a seed-funded, VC-backed, and NSF-supported startup developing revolutionary in-home health monitoring products. We’re looking for an experienced, meticulous, and proactive Quality Manager (Medical Device and Software) to help drive our day-to-day operations quality for production, postmarket surveillance, and manufacturing engineering.
Empo Health’s first product, the FDA-listed Empo® Footprint, is an in-home foot-scanning scale that helps doctors and patients monitor for early signs of diabetic foot ulcers, and the team has just launched the world-class device and associated Empo® Remote Health Link service to market. By identifying risks before they escalate, our technology aims to assist clinicians with preventing amputations and saving lives. Your work will directly contribute to ensuring execution of the quality processes that fit into Empo’s ability to detect the diabetic foot ulcers that impact millions of at-risk patients.
As a critical member of our small, fast-paced team, you will work closely with the founders and other early team members. You should be comfortable evaluating the execution of existing processes, suggesting new processes, and collaborating across a variety team functions.
If you’re passionate about remote care and helping prevent the worst outcomes for diabetic patients, then we’d love to hear from you!
This is a full-time position with the following responsibilities:
Collaborate with engineering and manufacturing functions to ensure quality processes are adhered to.
Support and implement methods and procedures for inspecting, testing and evaluating products and production equipment at Contract Manufacturing Organization (CMO).
Support and contribute to Material Review Board (MRB).
Lead, coordinate, and manage post-market surveillance (PMS) activities including, but not limited to, complaints, non-conformance, and Corrective and Preventive Action (CAPA).
Lead ongoing quality review board activities, as applicable.
Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with documented processes.
Coordinate document control and management in the Empo QMS.
Work with management to establish training programs per Empo role and/or associate.
Maintain the Internal Audit Program.
Coordinate and administer Management Review (MR) with support from the Management Representative.
Evaluate and maintain suppliers on the Approved Supplier List (ASL).
Implement, maintain, and optimize fit-for-purpose Standard Operating Procedures (SOPs) compliant with regulatory requirements.
Lead ongoing evaluation of fit-for-purpose electronic quality management system.
Support quality matters for firmware and non-product software in the manufacturing environment (test scripts and automated processes with custom or configured software)
Have 5+ years of experience in quality assurance or quality operations, preferably within the medical device industry.
Have a minimum of a Bachelor’s degree in engineering or another relevant field.
Are highly organized with strong attention to detail.
Are proactive, adaptable, and able to prioritize tasks independently.
Are readily willing to voice your findings, concerns, and suggestions to stakeholders as necessary.
Have experience with Corrective and Preventive Action (CAPA), post-market surveillance (PMS), and non-conformance investigations.
Have experience managing procedures compliant with ISO 13485, ISO 14971, IEC 62304, and the FDA's Code of Federal Regulations.
Possess strong knowledge of Quality Management Systems (QMS) and document control processes.
Can be onsite with Empo’s manufacturer, Sonic, in Fremont at least once per week and at Empo’s San Bruno HQ at least once per week.
Are excited to take ownership of Empo post-market Quality, making sure that Empo Health ships compliant products and meets post-market surveillance compliance. This will be as an individual contributor as Empo ramps up production volumes, before transitioning to building and managing a small internal Quality team.
Have experience working with medical technology startups.
Have familiarity with early-stage startup operations.
Have substantial experience in evaluating and improving manufacturing processes, especially with smaller Contract Manufacturers (CMs).
Hybrid-friendly working environment
“Take what you need” vacation and sick leave policy
Generous coverage for medical, dental, vision, and mental wellness plans
401(k) retirement plan with 4% match (after employment for 6 months)
12 week parental leave + part-time transition period at full pay (after employment for 12 months)
Equity incentive options for early full-time employees
Promoting diversity of backgrounds is extremely important at Empo Health. Although we do our best to list everything we are looking for in a candidate, we may be missing skills and/or attributes that could make you a great fit for the role. If you think you might fit this role but don’t perfectly match the description above, then please still apply! We would hate for both of us to miss out on a great opportunity.
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