Quality Engineer (Onsite: Irvine, CA)

SOLVENTUM • Irvine, CA

77d • $79,828 - $97,567

About The Position

Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. As a Quality Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. You will make an impact by performing quality activities leading to innovative applications and extensions of existing and new quality programs, engaging in investigations, problem resolution, corrective action responses, trending, and monitoring for nonconforming materials, complaints, and supplier issues. You will also implement quality engineering services for new and existing medical device products to ensure compliance with the quality system for all projects.

Requirements

• Bachelor’s Degree or higher in an engineering or science discipline from an accredited institution.
• Two (2) years of engineering experience in a medical device and/or company in a private, public, government, or military environment.
• Two (2) years of experience with United States Food and Drug Administration (FDA) regulations and recognized quality standards, including ISO 14971.

Nice To Haves

• Master’s degree in Biomedical Engineering, Manufacturing Engineering or Mechanical Engineering from an accredited institution.
• Professional certification, such as Certified Quality Engineer (CQE) through American Society for Quality (ASQ).

Responsibilities

• Perform quality activities leading to innovative applications and extensions of existing and new quality programs.
• Engage in investigations, problem resolution, corrective action responses, trending, and monitoring for nonconforming materials, complaints, and supplier issues.
• Implement quality engineering services for new and existing medical device products to ensure compliance with the quality system for all projects.
• Provide input to project planning, assist in establishing project objectives and priorities, lead teams of small project scope, and develop and implement quality system activities of minor complexity.
• Maintain an awareness of quality improvement and product opportunities and take initiative in suggesting, assessing, and implementing ideas.

Benefits

• Medical, Dental & Vision
• Health Savings Accounts
• Health Care & Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• Retirement Benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees