Quality Engineer II

Quality Engineer II

Location:

Irvine, CA (Onsite)

Contract:

12 month Contract with extension or conversion potential

• Medical
• Dental
• Holiday
• PTO 401K matching

Pay Rate Low: 40.00 | Pay Rate High: 44.00

Pay:  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.

• 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.

• 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.

• 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.

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