Instrumentation Quality Engineer

Overview

Instrumentation Quality Engineer opportunity to support medical device product development and quality activities. This role partners with R&D, Regulatory, and Operations teams to ensure compliance throughout the product lifecycle.

Location:

Lake Forest, CA.

Contract:

6 month contract with extension or conversion potential. Pay:  DOE. Benefits:
Medical, Dental, Holiday, PTO, 401K matching.

• Support quality activities for new and existing instrumentation products.
• Review design controls, risk management, verification/validation, and change control documentation.
• Assess product and process changes for quality and regulatory impact.
• Support investigations, root cause analysis, and CAPA activities.
• Ensure compliance with ISO 13485, ISO 14971, and GxP requirements.

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 2+ years of Quality Engineering experience in the medical device industry.
• Experience with design controls, risk management, change control, and validation activities.
• Strong communication and cross-functional collaboration skills.

Preferred: CQE certification, Six Sigma Green Belt, and knowledge of IEC 60601 standards.

Work Authorization: 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.