Sr. Quality Engineer

Summary:

• Perform Quality Engineering activities related to product development and ongoing cleanroom build support
• Ensure NPD processes comply to quality system and applicable regulatory standards.
• Update risk management and design control files. Maintain relevant quality documentation.
• Develop and execute test methods 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.

• 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 (i.e. Minitab) a plus.

• Experience in test method development including validation and/or fixture development
  Solid problem-solving, organizational, analytical, and critical thinking skills
• Bachelor's degree in engineering or Scientific field & 4+ years' experience
  -OR
  - Master's Degree
• Equivalent in Engineering or Scientific field & 3+ years' experience
• Good documentation and communication (e.g., written and verbal) skills with keen 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