What are the responsibilities and job description for the Instrumentation Quality Engineer position at Astrix?
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
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
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
Instrumentation Quality Engineer
Location: Lake Forest, CA
Contract: 6 month contract with extension or conversion potential
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.
- 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.
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