QA/RA Engineer - Medical Devices

Resourcing Edge•Reno, NV

9d•$80,000 - $110,000

About The Position

Join the growing team of OMEC Medical as a QA/RA Engineer and help shape quality and regulatory strategy across a diverse portfolio ranging from hand-held instruments to complete surgical robotics systems. OMEC Medical, an innovative medical device manufacturer, is seeking a highly motivated and experienced QA/RA Engineer with a broad, end-to-end understanding of the entire medical device product lifecycle. This individual will play a pivotal role in establishing and maintaining the Quality Management System (QMS) while providing critical quality and regulatory support for a rapidly evolving product pipeline, spanning Class II and Class III devices. You'll be instrumental in ensuring innovative devices seamlessly transition from concept to commercialization and beyond, meeting the stringent requirements of the FDA, EU MDR, and applicable international standards. The ideal candidate brings agility and adaptability to a dynamic, fast-paced environment, and is equally comfortable building foundational systems as they are executing at speed alongside cross-functional teams.

Requirements

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related scientific or engineering field
4–7 years of progressive experience in quality/regulatory engineering within the medical device industry
Demonstrated broad knowledge and practical experience across the entire medical device product lifecycle, from R&D and NPI through manufacturing, post-market, and sustaining activities
Held major responsibility for FDA 510(k) (or equivalent regulatory filing) submissions
Served as primary contact or SME during FDA or other regulatory body audits
Supported planning, execution, and documentation for design, manufacturing, and/or site validation
Led offsite vendor audits and qualifications
Cross-functionally collaborated with design, marketing, manufacturing, and sales to optimize regulatory strategies and minimize time to market
Represented quality or regulatory interests during formal design reviews
Deep expertise with FDA 21 CFR Part 820, EU MDR, and key international standards including: ISO 13485 | ISO 14971 | IEC 60601-1, IEC 62304 (Software) | IEC 81001-5-1 (Cybersecurity) | AAMI/SW96 (Cybersecurity Risk Management)
Knowledge of software and cybersecurity regulations as they apply to medical devices
Proven ability to thrive in a fast-paced, dynamic, and ambiguous environment
Strong analytical and problem-solving skills
Fluency in English (reading, writing, and verbal communication) required

Nice To Haves

Conversational Mandarin
Ability to travel internationally
Experience with Class III medical devices or surgical robotics

Responsibilities

Lead the design, implementation, and continuous improvement of OMEC's medical device QMS from the ground up
Develop, document, and maintain all essential QMS procedures, policies, and work instructions to ensure full regulatory compliance with FDA 21 CFR Part 820, EU MDR, and ISO 13485
Generate and review SOPs and technical documentation for the complete lifecycle of Class II and Class III medical products
Proactively monitor regulatory landscapes, interpret new guidelines, and strategically advise on integration into OMEC's quality framework
Provide dedicated quality engineering support throughout the entire NPI lifecycle from early-stage R&D through design transfer and commercialization
Drive efficient and compliant design control processes adapted to the fast-paced nature of NPI
Proactively identify quality risks, define critical quality attributes, and implement appropriate controls to ensure product safety, effectiveness, and compliance
Represent quality and regulatory interests during formal design reviews
Lead and contribute to comprehensive risk management activities per ISO 14971, ensuring risks are effectively identified, evaluated, controlled, and monitored particularly during rapid design iterations
Apply standards expertise including IEC 60601-1, IEC 62304 (Software), IEC 81001-5-1 (Cybersecurity), and AAMI/SW96 (Cybersecurity Risk Management)
Hold major responsibility for FDA 510(k) submissions and/or other regulatory filings (PMA, De Novo, CE Marking, etc.)
Cross-functionally collaborate with design, marketing, manufacturing, and sales to optimize regulatory strategies and minimize time to market
Serve as the primary contact and subject matter expert (SME) during FDA inspections, Notified Body audits, and ISO 13485 certification audits
Support planning, execution, and documentation for design, manufacturing, and/or site validation activities
Collaborate with supply chain to qualify new suppliers and components critical for new products
Lead offsite vendor audits and qualifications; manage ongoing supplier quality performance monitoring throughout the product lifecycle
Support post-market surveillance activities including complaint handling, vigilance reporting, and field actions in compliance with global regulations
Feed post-market insights back into the product development process
Work closely and agilely with R&D, manufacturing, regulatory affairs, and commercial teams — integrating quality and regulatory principles throughout the product lifecycle
Influence design and manufacturing decisions to ensure compliance and support rapid development cycles while maintaining quality excellence