@ Team Panthr
Expect the unexpected!
We are the first zero-BS talent matchmaker. Empowering individuals through their job seeking journey whilst finding the perfect candidate that fits not only a role but a company vision.
From start to finish, we focus on making the recruitment process smooth and positive for everyone involved.
With more than 15 years of experience in the field, we make use of real data insights, professional expertise and technology. Although we offer worldwide service, our feet are always on the ground and trust is at the heart of what we do, built on transparency and a genuine commitment to seeing you succeed.
Meet our client
Health Tech Startup
About the role
As a Senior RA/QA Engineer you will play a key role in ensuring that our medical devices meet the highest standards of quality, safety, and regulatory compliance. You will drive and sustain regulatory and quality processes throughout the entire product lifecycle—from design and development to transfer, release, and post-market activities. This role partners closely with cross-functional teams across the company to ensure product readiness for both US and EU markets.
Your responsibilities:
Quality Management System (QMS) & Compliance: Maintain and improve QMS processes, support ISO 13485 certification, manage audits, CAPA, nonconformances, supplier controls, and document control.
Design Controls & Risk Management: Oversee risk management activities aligned with ISO 14971 and ensure design documentation is compliant and up-to-date.
Software Lifecycle & Validation: Collaborate with software/firmware teams to implement compliant software development lifecycles, verification, and validation evidence.
Safety, Biocompatibility & Usability Support: Coordinate compliance activities related to IEC 60601, ISO 10993, and IEC 62366, including risk mitigation and testing strategies.
Regulatory Strategy & Documentation: Support EU MDR deliverables, technical documentation, PMS, and vigilance readiness. Interface with external partners (Notified Bodies, labs, consultants) to ensure alignment and compliance.
Cross-Functional Leadership: Serve as a core RA/QA team member for product development programs, mentor junior team members, and ensure inspection-ready documentation and consistent quality standards
About You:
Bachelor’s degree in engineering, biomedical sciences, or a related field (advanced degree a plus).
5+ years of experience in medical device RA/QA, with hands-on ownership of deliverables and cross-functional execution.
Strong working knowledge of 21 CFR 820, ISO 13485, EU MDR 2017/745, ISO 14971, IEC 62304, IEC 60601, ISO 10993, IEC 62366.
Proven ability to create traceable, inspection-ready records and drive closure on CAPA, nonconformances, and risk controls.
Excellent communication skills to collaborate with engineering, operations, and external regulatory bodies.
Preferred: experience with FDA submissions, EU CE marking, connected devices, software validation, and audits.
Senior Regulatory Affairs & Quality Assurance (RA/QA) Engineer – Medical Devices • San Diego, United States
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