The Quality Assurance Specialist – Design & Development (Electronics) will support quality activities across the design and development lifecycle of electronic products. This role ensures adherence to ISO 13485 and ISO 9001 quality standards, with a focus on design controls, risk management, verification and validation, and regulatory compliance. The position reports to the QA Manager – NPI and works closely with R&D, manufacturing, and regulatory teams.
Responsibilities
- Support quality assurance activities throughout design and development phases
- Review and approve documentation related to design, development, and change control processes
- Ensure compliance with design controls, verification and validation requirements, and traceability standards
- Engage in risk management activities and collaborate with regulatory functions
- Support planning and execution of verification and validation for design lifecycle changes
- Maintain quality system records, including CAPA, non-conformances, and performance metrics
- Provide guidance on document management systems and quality-related procedures
- Support continuous improvement initiatives, training programs, and management review activities
Requirements
- Bachelor of Science degree in Engineering or Science, such as electronics, microelectronics, or electro-mechanical engineering, or equivalent experience
- Approximately 5 years of experience in product design, development, or quality assurance within a regulated environment governed by ISO 9001 or ISO 13485
- Experience supporting the development of electronic products
- Solid understanding of design control principles, including requirements definition, verification, validation, and risk management
- Working knowledge of document control, change management, non-conformance handling, and CAPA systems
- Familiarity with applicable technical standards such as IEC, ISO, and ASTM
- Bachelor’s degree in a relevant engineering or science field related to electronics or electro-mechanical systems, or equivalent practical experience
- Five years of professional experience in design and development or quality assurance within a regulated industry compliant with ISO 9001 or ISO 13485
- Experience must include involvement in the design and development of electronic products, preferably for laboratory or in vitro diagnostic (IVD) applications
- Demonstrated understanding of quality assurance principles as applied to design and development, aligned with industry best practices in regulated environments
- Proven experience with design inputs, outputs, verification, validation, planning, reporting, and risk management processes
- Knowledge of relevant technical standards including ASTM, IEC, and ISO
- Practical experience with Document Management Systems, Change Control, non-conformance, and CAPA systems
Nice to Have
- Completion of ISO 9001 or ISO 13485 Internal Auditor training
- Experience working in medical device or in vitro diagnostic (IVD) environments
- Knowledge of statistical validation, process validation, or computer systems validation
- Experience drafting requirements, test protocols, or verification reports
- Internal auditor certification or relevant training in ISO 9001 or ISO 13485 standards
- Prior work in a medical device or IVD setting is advantageous
- Understanding of statistical, process, or computer systems validation is highly desirable
- Experience authoring design inputs, design outputs, test protocols, or test reports is strongly preferred
Tech Stack
ISO 9001, ISO 13485, Design Controls, Verification & Validation (V&V), Risk Management, Document Management Systems, Change Control, Non-Conformance Systems, CAPA Systems, IEC Standards, ASTM Standards
Team
Cross-functional collaboration with R&D, technical transfer, manufacturing, product management, and regulatory affairs; reports to QA Manager – NPI
