Instrumentation Quality Engineer

Instrumentation Quality Engineer Astrix Technology Group - 3.4 Lake Forest, CA Job Details 1 day ago Benefits Health insurance Dental insurance Paid time off 401(k) matching Qualifications Medical device validation Defect resolution root cause analysis Six Sigma Green Belt GxP ISO standards Preventive action implementation Engineering Corrective and preventive actions (CAPA) Mid-level Collaboration with product development teams Six Sigma Bachelor's degree in engineering Quality risk management Design controls Biomedical regulatory compliance Regulatory compliance analysis Document change management 2 years Communication skills Product quality failure Certified Quality Engineer Regulatory compliance management Cross-functional communication Failure analysis Engineering quality assurance Full Job Description 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 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! INDBH