Job Description:
In this role, you will work closely with R&D, Regulatory, Operations, and other cross-functional stakeholders to provide hands-on quality engineering support across the product development lifecycle. You will contribute to key activities such as design controls, risk management, verification and validation, supplier-related quality support, change control, and product transfer. The ideal candidate brings strong technical judgment, demonstrated quality capability, and the ability to operate independently in a fast-paced environment.
Roles & Responsibilities:
- Provide hands-on quality engineering support for new product development projects and design changes to existing instrumentation products
- Ensure quality requirements are appropriately applied throughout development, documentation, verification, validation, and transfer activities
- Partner with project teams to provide practical quality guidance, technical assessment, and risk-based decision support that helps keep development activities moving forward
- Review and approve design control deliverables, including risk management files, verification and validation documentation, and related development records
- Evaluate product and process changes for quality and regulatory impact, and support change control activities from assessment through implementation
- Partner with cross-functional teams to investigate deviations, support root cause analysis, and drive corrective and preventive actions as needed
- Maintain compliance with applicable GxP requirements, standard operating procedures, and documentation practices
Education & Experience:
- Bachelor's degree in engineering, life sciences, or a related technical field
- 2+ years of quality engineering experience in the medical device industry, including direct support of instrumentation or electromechanical product development in an ISO 13485 environment
- Experience with design controls, change control, and product impact assessments
- Working knowledge of applicable medical device quality system and regulatory requirements, including ISO 13485, design controls and GxP principles
- Ability to work effectively across global, cross-functional teams, communicate clearly with technical and non-technical stakeholders, and contribute with minimal ramp-up
- Experience with risk management in accordance with ISO 14971
- Experience reviewing or supporting verification and validation protocols, reports, and related documentation
- Statistical knowledge to support sample size determination and the design of verification and validation studies
- Working knowledge of applicable product and safety standards, such as the IEC 60601 series and ISO 14971
- ASQ Certified Quality Engineer (CQE) certification
- Six Sigma Green Belt or higher.
- Strong communication, organization, collaboration, and independent problem-solving skills.