Quality Engineer II
Listed on 2026-08-22
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Pay Rate Low: 40.00 | Pay Rate High: 44.00
Exciting Quality Engineer II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care
Quality Engineer II
Location:
Irvine, CA (Onsite)
Contract:12 month Contract with extension or conversion potential
Benefits
:
Medical, Dental, Holiday, PTO 401K matching
Pay: doe
Provide hands-on quality engineering support for new product development and design changes for instrumentation products. Partner with R&D, Regulatory, and cross-functional teams throughout the product development lifecycle.
Key Responsibilities:
- Support design controls, risk management, verification/validation, change control, and product transfer.
- Review and approve design control, risk management, V&V, and development documentation.
- Provide quality guidance and risk-based decision support to development teams.
- Assess product and process changes for quality and regulatory impact.
- Support deviation investigations, root cause analysis, and CAPA activities.
- Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements.
Minimum Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or related technical field.
- 2+ years of Quality Engineering experience in the medical device industry.
- Experience supporting instrumentation or electromechanical product development in an ISO 13485 environment.
- Experience with design controls, risk management, change control, and V&V.
- Working knowledge of ISO 13485, ISO 14971, and medical device quality systems.
- Strong communication, collaboration, and independent problem-solving skills.
Preferred:
- Experience with statistical methods and V&V study design.
- Knowledge of IEC 60601 and other applicable product/safety standards.
- ASQ CQE or Six Sigma certification.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
Work Authorization Requirement
Candidates must be authorized to work in the United States on a permanent basis.
Sponsorship (including H-1B, OPT, CPT, etc.) is not available for this role now or in the future.
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