Quality Engineer II

Astrix; Irvine (CA); On-site; USD 114,616,000 - 126,188,000; Full time

Benefits offered by this job

Medical

Dental

Holiday

PTO 401K matching

Job summary

Astrix in Irvine, CA is seeking a Quality Engineer II to provide hands-on quality engineering support for medical device development and design changes. This onsite role partners with R&D, Regulatory, and cross-functional teams to ensure product quality throughout the lifecycle.

The position requires 2+ years in medical device quality engineering, knowledge of design controls, risk management, V&V, and ISO 13485.

Qualifications

• Bachelor's degree in engineering or life sciences.
• 2+ years quality engineering in the medical device industry.
• Experience with design controls, risk management, V&V in ISO 13485 environments.
• Strong communication and 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

Risk management

V&V

ISO 13485

Medical devices

Communication

Education

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

Job description

Quality Engineer II

Location: Irvine, CA (Onsite)

Contract: 12 month Contract with extension or conversion potential

Benefits

• Medical
• Dental
• Holiday
• PTO 401K matching

Pay

Pay Rate Low: 40.00 | Pay Rate High: 44.00

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.

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