QA/RA Engineer

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 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

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 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

Beneficial Skills

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