Quality Engineer

Job Description :

Pay Range: $54.18hr - $59.18hr

• 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.

• 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.

• 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.
• 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.