A Product Quality Engineer evaluates and tests products and manufacturing systems, to ensure that products are produced that meet quality and performance standards as well as safety and regulatory requirements. Develops product quality standards and monitors production and product testing.
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:
40.00-44.00 doe Quality Engineer - Medical Devices 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. INDBH #LI-RL1
