QA/RA Engineer - Medical Devices

Resourcing Edge; Reno (NV); On-site; USD 110,000 - 170,000; Full time

Job summary

OMEC Medical is seeking a QA/RA Engineer to design and sustain the Quality Management System and provide regulatory support across a Class II/III product portfolio.

The ideal candidate will lead QMS development, drive design controls, risk management, and regulatory submissions while collaborating with R&D, manufacturing, and commercial teams to accelerate safe product launches.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical engineering or related field.
• 4–7 years of quality/regulatory engineering in medical devices.
• Broad knowledge of the medical device lifecycle from R&D to manufacturing and post‑market.
• Led FDA 510(k) submissions or equivalent regulatory filings.
• Served as SME during FDA or regulatory body audits.
• Experience planning and documenting design validation and supplier qualification.
• Strong English communication and ability to thrive in fast-paced environments.

Responsibilities

• Lead the design, implementation, and continuous improvement of the QMS from the ground up.
• Develop, document, and maintain QMS procedures and work instructions for FDA 21 CFR Part 820, EU MDR, ISO 13485.
• Generate and review SOPs and documentation for Class II and III products.
• Advise on regulatory strategy and maintain audit readiness; interface with FDA and Notified Bodies.
• Support NPI lifecycle from R&D through design transfer and commercialization.
• Lead risk management per ISO 14971 and cybersecurity considerations per IEC standards.
• Coordinate cross-functionally with design, manufacturing and marketing to optimize time‑to‑market.
• Perform and manage supplier quality activities and offsite vendor audits.
• Support post‑market surveillance and field actions as required.

Skills

Quality/regulatory engineering

FDA submissions

Design reviews

QMS implementation

ISO 13485

FDA 21 CFR Part 820

Cybersecurity standards

Cross-functional collaboration

Regulatory inspections

Surgical robotics

Education

Bachelor's degree in Mechanical Engineering

Job description

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.

What You’ll Do

Quality Management System (QMS)

• 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

New Product Introduction (NPI) & Design Controls

• 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

Risk Management

• 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)

Regulatory Affairs & Submissions

• 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 minimise time to market
• Serve as the primary contact and subject matter expert (SME) during FDA inspections, Notified Body audits and ISO 13485 certification audits

Validation & Supplier Quality

• 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

Post-Market Surveillance

• 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

Cross-Functional Collaboration

• 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

What You’ll Bring

Required Qualifications

• 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 optimise regulatory strategies and minimise 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

Beneficial Skills

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

OMEC Medical is an equal opportunity employer committed to building an inclusive, innovative team.