Job Description
Our medical device manufacturing client, OMEC Medical, is seeking a highly motivated and experienced quality engineer with a broad, end-to-end understanding of the entire medical device product life cycle. This individual will play a pivotal role in establishing and maintaining the quality management system (QMS) while providing critical quality support for their rapidly evolving product pipeline. You’ll be instrumental in ensuring innovative devices seamlessly transition from concept to commercialization and beyond, meeting stringent requirements of the FDA, and more.
The ideal candidate will possess the agility and adaptability necessary to navigate the dynamic environment of an evolving medical device company, ensuring quality excellence at every stage of product development and post-market activities.
What the Quality Engineer will do:
- Lead the design, implementation, and continues improvement of our 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 international standards including ISO 13485 .
- Also proactively monitor regulatory landscapes, interpret new guidelines, and strategically advise on the integration into our quality framework.
- Provide dedicated quality engineering support throughout the entire NPI lifecycle, from early-stage research and development through design transfer and commercialization. This included proactively identifying quality risks, defining critical quality attributes, and implementing appropriate controls to ensure product safety, effectiveness, and compliance.
- Act as a subject matter expert on key international standards, ensuring their practical application throughout the product lifecycle and within the QMS. Standards such as ISO 13485, ISO 14971, IEC 60601-1, and more.
- Drive the implementation of efficient and compliant design control processes, adapting them to the fast-paced nature of NPI.
- Lead and contribute to comprehensive risk management activities per ISO 14971, ensuring that risks are effectively identified, evaluated, controlled, and monitored in an iterative and responsive manner, particularly during rapid design iterations.
- Take a lead role in preparing the organization for successful internal, regulatory inspections, and notified body audits (e.g. FDA inspections, Notified body audits for EU MDR, and ISO 13485 certification).
- Support and participate in audit activities, effectively articulating our QMS and compliance posture, addressing findings, and implementing robust corrective and preventive actions.
- Collaborate with supply chains to qualify new suppliers and components critical for new products, and ensure ongoing supplier quality management, including audits and performance monitoring, throughout the product’s life cycle.
- Support post-market surveillance activities, including complaint handling, vigilance reporting, and field actions, ensuring compliance with global regulations and feeding insights back into the product development process.
- Apply a comprehensive understanding of the entire medical device product life cycle to ensure quality is embedded from ideation and feasibility through design and development, verification and validation, manufacturing, distribution, post-market surveillance, and eventual end-of-life.
- Work closely and agilely with R&D, manufacturing, regulatory affairs, and other 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.
What the Quality Engineer needs to have:
- Bachelor’s degree in mechanical engineering, electrical engineering, biomedical engineering, or a related scientific or engineering field.
- Extensive experience moving products through quality/regulatory landscapes is required
- 4-7 years of progressive experience in product/systems engineering within the medical device industry.
- Demonstrated board knowledge and practical experience across the entire medical device product life cycle, from R&D and NPI through manufacturing, post-market, and sustaining activities
- Knowledge of software and cybersecurity regulations
- Deep expertise and practical experience with FDA Quality System Regulation (21 CFR Part 820) and EU Medical Device Regulation (MDR).
- Strong familiarity and application experience with key international standards, including ISO 13485, ISO 14971, and IEC 60601-1 (and relevant collateral standards)
- Proven ability to work effectively in a fast-paced, dynamic, and ambiguous environment, demonstrating adaptability and agility.
- Strong analytical and problem-solving skills
- Fluency in English required (reading, writing, and verbal communication) to effectively communicate with clients, prepare written reports, and collaborate with internal teams
Job Tags
Full time