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Instrumentation Quality Engineer

Job

Astrix

Laguna Hills, CA (In Person)

$85,280 Salary, Full-Time

Posted 1 week ago (Updated 1 day ago) • Actively hiring

Expires 7/4/2026

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Job Description

Instrumentation Quality Engineer at Astrix Instrumentation Quality Engineer at Astrix in Laguna Hills, California Posted in 4 days ago.
Type:
full-time
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 Contract:
6 month contract with extension or conversion potential
Pay:
38.00-44.00
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! INDBH