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Instrumentation Quality Engineer

Job in Lake Forest, Orange County, California, 92630, USA
Listing for: Astrix Technology
Contract position
Listed on 2026-06-02
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer, Process Engineer
Job Description & How to Apply Below
** Instrumentation Quality Engineer*
* Engineering

Lake Forest, California, US

+ Added - 26/05/2026

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!

INDBH

LI-RL1

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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