Instrumentation Quality Engineer

Exciting Quality Engineer 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
Instrumentation Quality Engineer
Location: Lake Forest, CA
Contract: 6 month contract with extension or conversion potential
Pay: DOE
Benefits: Medical, Dental, Holiday, PTO 401K matching
We are seeking an Instrumentation Quality Engineer 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.
Responsibilities:

• Support quality activities for new and existing instrumentation products.
• Review design control, 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.

Qualifications:

• 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 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.
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!
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