What are the responsibilities and job description for the Quality Assurance Engineer position at Katalyst CRO?
Job Summary
- Quality Assurance Engineer responsible for providing design assurance support for new product development and on-market medical devices.
- The role focuses on facilitating design controls, ensuring regulatory compliance, supporting manufacturing-related design changes, and contributing to verification, validation, and risk management activities throughout the product lifecycle.
- Provide design assurance support for new product development and sustaining medical device projects
- Participate independently in new product development projects to ensure design inputs are clearly defined and met
- Ensure design verification and validation activities are appropriate, compliant, and support input requirements, including test method validation
- Conduct thorough reviews and audits of Design History File (DHF) documentation, including design plans, inputs, outputs, verification, validation, design changes, and design transfer documentation
- Review and audit Requirements Trace Matrix to ensure accuracy and compliance with medical device design control requirements
- Support sustaining product projects by ensuring continued compliance with design inputs and completion of required verification, validation, and risk management activities
- Collaborate with R&D to coordinate design elements of Risk Management files in compliance with applicable standards and internal policies
- Coordinate Health Risk Assessment activities for on-market products, including problem definition, impact analysis, and evaluation
- Assess product change requests for design impact and determine required supporting information for implementation
- Act as a key advocate for compliance by reviewing product and project documentation and communicating assessments effectively
- Work collaboratively on cross-functional project teams and take leadership on critical tasks as needed
- Bachelor's degree in a technical discipline
- 25 years of experience, preferably in the medical device industry
- Experience with FDA Quality System Regulations, especially Design Control requirements
- Knowledge of ISO 13485, Medical Device Directive, and ISO 14971 Risk Management
- Familiarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards
- Working knowledge of verification and validation requirements for regulated products
- Experience in requirements analysis and development of testable and measurable specifications
- Strong ability to work effectively within project teams with good communication and compliance-focused judgment