Advanced Quality Engineer (Onsite - Irvine, CA)

Thank you for your interest in joining Solventum. 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. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Advanced Quality Engineer (Solventum)

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As an Advanced 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. Here, you will make an impact by:

• Assuming responsibility for performing and guiding self-initiated quality activities leading to innovative applications and extensions of existing and new quality programs of importance to the business.

• Leading investigations, problem resolution, corrective action responses, trending, and monitoring for nonconforming materials, complaints, and supplier issues.

• Implementing quality engineering services for new and existing medical device products to ensure compliance with the quality system for all projects.

• Actively participating in project planning, establishing project objectives and priorities, leading teams, and developing and implementing quality system activities of major complexity.

• Maintaining an awareness of quality improvement and product opportunities and being productive in suggesting, assessing, and implementing ideas.

Your Skills and Expertise 

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s Degree or higher in an engineering or science discipline (completed and verified prior to start) AND five (5) years of combined experience in quality engineering, engineering, and/or manufacturing engineering in a regulated environment, including private, public, government, or military environments

Additional qualifications that could help you succeed even further in this role include:

• Master’s degree in Biomedical Engineering, Manufacturing Engineering or Mechanical Engineering (completed and verified prior to start) from an accredited institution and seven (7) years of engineering experience in a medical device and/or pharmaceutical company in a private, public, government, or military environment.

• Seven (7) years of experience with United States Food and Drug Administration (FDA) regulations and recognized quality standards, including ISO 14971 in a private, public, government, or military environment.

• Professional certification, such as Certified Quality Engineer (CQE) through American Society for Quality (ASQ).

• Skills include project management, statistical analysis using Minitab, Power BI, and conducting internal and external audits.

• Six Sigma Green or Black Belt, post market analysis experience, change management experience, and experience participating in design reviews.

Work location:

• Onsite - Irvine, California

Travel: May include up to 5% domestic and international

Relocation Assistance: May be authorized