Position Title: Senior Design Quality Engineer Work Location: Irvine, CA 92614 Assignment Duration: 18 Months Work Arrangement: Onsite
Position Summary: As part of our Quality Engineering team, you will work closely with our R&D and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.
Key Responsibilities:
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.
Qualification & Experience:
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
Additional Information:
Strong preference: candidates with previous experience in NPD, Design Assurance (DA), Quality Engineering.
Role will not be for full time conversion.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 54.00/hr.
