Quality Engineer II (Medical Devices)

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We are seeking a Quality Engineer to work on a team at our client site in Irvine, CA. This position is directly related to quality engineering for medical products, not software, with 2-4 years of experience required. No 3rd party candidates can be considered.

Summary:

The main function of a quality engineer is to apply engineering theory and principles to ensure compliance with regulatory requirements and company systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Job Responsibilities:

• Optimize processes using engineering methods to drive continuous improvement initiatives.
• Execute risk management activities through-out the post-market phase and ensure compliance with regulatory requirements. Support, update, and maintain technical content of risk management files and ensure integration with other aspects of the quality system.
• Collaborate with cross-functional stakeholders and ensure oversight of quality issues that require investigation through the different phases.
• Other incidental duties as assigned by leadership
  
  

Skills:

• Innovative, analytical and strong problem-solving skills.
• Team player and detail oriented.
• Ability to manage competing priorities in a fast-paced environment
• Knowledge of Six Sigma concepts with ability to apply to work processes
• Data analytics experience
  
  

Education/Experience:

• Bachelor's degree in engineering required.
• 2-4 years experience required.
  
  

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.