Back to jobs

Senior Quality Assurance Engineer

Job description

Senior Design Assurance Engineer

Our client is a class III medical device organization seeking a highly experienced and impactful Senior Design Assurance Engineer. This role is crucial in ensuring the quality and compliance of their cutting-edge products, ultimately contributing to improved vision and quality of life for patients worldwide.
Our client is dedicated to empowering surgeons with advanced devices and services, driven by a commitment to quality and continuous improvement. They foster a collaborative and inclusive culture, valuing excellence, passion, innovation, and accountability.

Role Overview:
The Senior Design Assurance Engineer will ensure products meet stringent quality goals and regulatory requirements, including FDA regulations, ISO 13485, EU MDR, MDSAP, IEC 62366-1 (Usability Engineering), and ISO 14971 (Risk Management).

Duties and Responsibilities:
  • Partner with R&D teams globally (USA, MDSAP) to ensure robust design control, adherence to procedures, and completion of required outputs.
  • Lead and manage all design assurance and usability engineering activities for R&D projects.
  • Ensure meticulous maintenance of Design History Files (DHF) and project documentation within the Document Control System (e.g., Master Control).
  • Oversee design gate reviews, ensuring consistency and accuracy of documentation.
  • Serve as a core team leader for design control projects, reviewing verification protocols and reports, and advising on approvers.
  • Contribute to the development and approval of design development plans, verification and validation protocols/reports, and design transfer.
  • Review labeling and biocompatibility study documents (ISO 10993-1).
  • Review and approve R&D documents (IQ, OQ, PQ, WI, etc.).
  • Coordinate design transfer to manufacturing and regulatory technical dossiers.
  • Drive process improvement initiatives within Design Assurance and Usability Engineering.
  • Maintain and enhance global operating procedures and work instructions.
  • Support lifecycle management of marketed products.
  • Conduct design assurance training for global R&D teams.
  • Support internal and external audits related to R&D projects.
  • Develop corrective action plans for audit findings.
  • Manage design change control for design control projects.
  • Thoroughly review R&D technical reports for quality assurance.
  • Foster a performance-driven culture.
Requirements:
  • Experience:
  • Minimum 6 years of quality experience in the medical device industry.
  • Experience with New Product Development (NPD) projects.
  • Experience with test method validation.
  • Demonstrated expertise in FDA regulations, ISO 13485, EU MDR, MDSAP, ISO 14971, IEC 62366-1, ISO 17025, and ISO 10993.
  • Skills/Accreditations:
  • Strong analytical and problem-solving skills.
  • Proven drive for results and persistence.
  • Experience leading in a matrix organization and global teams.
  • Excellent English communication skills (written, verbal, presentation).
  • Strong intercultural experience and collaboration skills.
  • Strong project management skills.
  • Understanding of the medical device business (ophthalmology preferred).
  • Knowledge of US, EU, and JP medical device standards.
  • Excellent leadership skills and alignment with core values.
  • Ability to work independently.
  • Academic Qualifications:
  • BS in Engineering or Life Sciences (10 years experience); MS preferred.
  • ISO 13485/MDSAP Auditor/Lead Auditor Certification preferred.
  • ASQ Certification (CQE/CQA) preferred.
  • Six Sigma Green Belt preferred.
  • Travel:
  • Up to 20% (domestic and international and APAC regions)