Quality Engineer II

Astrix Inc.; Irvine (CA); On-site; USD 55,000 - 61,000; Part time

Job summary

Astrix Inc. in Irvine, CA is seeking a Quality Engineer II to support medical device development with hands-on quality engineering across the lifecycle, partnering with R&D, Regulatory, and cross‑functional teams.

This onsite 12‑month contract with potential extension requires a Bachelor’s in Engineering or Life Sciences, 2+ years in medical device quality, and knowledge of ISO 13485/14971, design controls, V&V, and CAPA. Strong communication and problem solving are essential.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 2+ years of Quality Engineering experience in the medical device industry.
• Experience with instrumentation or electromechanical product development in an ISO 13485 environment.
• Experience with design controls, risk management, change control, and V&V.
• Working knowledge of ISO 13485, ISO 14971, and medical device quality systems.
• Strong communication, collaboration, and independent problem-solving skills.

Responsibilities

• Support design controls, risk management, verification/validation, change control, and product transfer.
• Review and approve design control, risk management, V&V, and development documentation.
• Provide quality guidance and risk-based decision support to development teams.
• Assess product and process changes for quality and regulatory impact.
• Support deviation investigations, root cause analysis, and CAPA activities.
• Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements.

Skills

Quality engineering

Design controls

V&V

CAPA

Problem solving

Team collaboration

Education

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Tools

ISO 13485

ISO 14971

Job description

Pay Rate Low: 40.00 | Pay Rate High: 44.00

Exciting Quality Engineer II 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

QualityEngineer II
Location:Irvine, CA (Onsite)
Contract:12 month Contract with extension or conversion potential
Benefits: Medical, Dental, Holiday, PTO 401K matching
Pay: 40.00-44.00 doe

Quality Engineer – Medical Devices

Provide hands-on quality engineering support for new product development and design changes for instrumentation products. Partner with R&D, Regulatory, and cross-functional teams throughout the product development lifecycle.

Key Responsibilities:

• Support design controls, risk management, verification/validation, change control, and product transfer.


• Review and approve design control, risk management, V&V, and development documentation.


• Provide quality guidance and risk-based decision support to development teams.


• Assess product and process changes for quality and regulatory impact.


• Support deviation investigations, root cause analysis, and CAPA activities.


• Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements.

Minimum Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.


• 2+ years of Quality Engineering experience in the medical device industry.


• Experience supporting instrumentation or electromechanical product development in an ISO 13485 environment.


• Experience with design controls, risk management, change control, and V&V.


• Working knowledge of ISO 13485, ISO 14971, and medical device quality systems.


• Strong communication, collaboration, and independent problem-solving skills.

Preferred:

• Experience with statistical methods and V&V study design.


• Knowledge of IEC 60601 and other applicable product/safety standards.


• ASQ CQE or Six Sigma certification.

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!

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.

INDBH

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