Design Assurance Specialist for Medical Devices and Systems
vor 3 Wochen
Transforming Healthcare and Manufacturing with Innovative Solutions
At Novanta, we empower our global customers with engineered components and sub-systems that deliver extreme precision and performance for mission-critical applications.
We are seeking a talented Design Assurance Engineer to join our team. As a key member of our product development team, you will be responsible for creating an overall quality plan, reviewing design verification and validation specifications, and leading/contributing to risk management, FMEA, and other quality-related tasks.
Key Responsibilities:
- Support the creation of an overall superior quality plan including document plan and overall VnV plan
- Review design verification and validation test specifications for medical devices (equipment and consumables)
- Review design control documents according to GLP, GDP, and CFR820
- Participate in the product and design FMEA team
Collaboration and Innovation:
- Contribute to the content of the risk management throughout the product development
- Review the systematic and completeness of the risk analysis
- Evaluate risk-reducing measures regarding impact on severity of damage and probability of occurrence
- Develop and review evidence for implementation and effectiveness of measures
Requirements:
- Completed technical and/or physical studies
- At least 2 years of professional experience
- Experience with product quality in a highly regulated industry (medical device, automotive, aviation)
- Experience in theory and application of quality methods and techniques
- English language skills (B2) required
- Quality-conscious, trustworthy, and reliable
- Team player
- Good communication skills
- Structured and systematic way of working
- Willingness to travel to all locations and business contacts (10%)
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