Quality Engineer II

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: 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


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