Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)
Skills
Analytical Skill
Attention To Detail
Communication
Conflict Resolution
Critical Thinking
Design Controls
Documentation
ISO 13485
Job Details
We are looking for Quality Engineer for our client in Irvine, CA
Job Title: Quality Engineer
Job Type: Contract
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.
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