Principal Quality Engineer - Medical Devices (Equity + PTO)

Jobot; Irvine (CA); On-site; USD 89,544 - 117,096; Full time

Benefits offered by this job

Company Equity!

Excellent medical, dental, & vision package!

401(k) with a match!

Generous PTO!

Opportunity to make a difference!

Job summary

A leading medical device company is seeking an experienced Principal Quality Engineer to lead quality initiatives ensuring compliance with FDA regulations. The ideal candidate will have over 12 years of experience in quality engineering and in-depth knowledge of ISO 13485 and CAPA management. This is a contract-to-hire position that not only offers competitive compensation but also an opportunity to significantly impact patient care and quality of life. Benefits include company equity and comprehensive medical packages.

Qualifications

• 12+ years of experience in a quality engineering role.
• Extensive knowledge of quality systems in the medical device industry.
• Certifications such as CQE or CQA are preferred.

Responsibilities

• Lead quality systems compliance with FDA and ISO 13485.
• Analyze and manage CAPA for quality issues.
• Conduct audits to maintain regulatory compliance.
• Collaborate with teams for continuous improvement.
• Provide consultation on quality systems and risk management.

Skills

Strong background in quality engineering

Knowledge of FDA regulations

ISO 13485 expertise

CAPA management

Problem-solving methodologies

Education

Bachelor's degree in Engineering, Quality Assurance, or related field

Job description

A leading medical device company is seeking an experienced Principal Quality Engineer to lead quality initiatives ensuring compliance with FDA regulations. The ideal candidate will have over 12 years of experience in quality engineering and in-depth knowledge of ISO 13485 and CAPA management. This is a contract-to-hire position that not only offers competitive compensation but also an opportunity to significantly impact patient care and quality of life. Benefits include company equity and comprehensive medical packages.