KH
Sr Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Senior
5 months ago
- Risk Management
- Minitab
5 months ago
Not enough detail in this posting to match
- The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment.
- The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams.
- Perform Quality Engineering activities related to product development and ongoing cleanroom build support
- Ensure NPD processes comply with the quality system and applicable regulatory standards
- Update risk management and design control files and maintain relevant quality documentation
- Develop and execute test method validations and qualification plans
- Support design verification and facilitate process validation and commercialization activities related to multi-site transfer
- Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing
- Other duties assigned by Leadership
- Bachelor's degree in Engineering or Scientific field & 4+ years' experience OR Master's degree or equivalent in Engineering or Scientific field & 3+ years' experience
- Strong preference for candidates with experience in NPD, Design Assurance (DA), and Quality Engineering
- Proficient understanding of medical device operations and/or manufacturing processes; medical device experience strongly preferred
- Relevant experience in product development, quality assurance, and/or related fields
- Knowledge and understanding of Engineering and Quality principles, theories, and concepts
- Understanding of ISO 13485
- Experience developing, updating, and maintaining technical content of risk management files
- Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) is a plus
- Experience in test method development including validation and/or fixture development
- Solid problem-solving, organizational, analytical, and critical thinking skills
- Good documentation and communication skills with attention to detail
- Ability to build productive working relationships and interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
Sr Quality Engineer · Katalyst Healthcares & Life Sciences