Quality Engineer

SOLVENTUM•Monrovia, CA

13d•$106,000 - $145,750•Onsite

About The Position

Solventum is a new healthcare 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. 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 assuming responsibility for initiating and performing defined quality activities leading to new or improved processes or systems on a program level. You will support failure investigations and problem resolution, implementing quality engineering services for new and existing medical device products to ensure compliance with the quality system for all projects. You will participate in project planning, assist in establishing project objectives and priorities, and lead medium-sized teams. You will maintain an awareness of quality improvement and product opportunities and be productive in suggesting and testing ideas.

Requirements

Bachelor’s Degree or higher in engineering or science from an accredited institution and three (3) years of quality engineering experience in a medical device and/or pharmaceutical company in a private, public, government or military environment OR High School Diploma/GED from an accredited institution and a minimum of (10) ten years of Quality experience in a medical device and/or pharmaceutical company in a private, public, government or military environment
One (1) year experience with United States Food and Drug Administration (FDA) regulations and recognized quality standards, including ISO 14971
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

Professional certification, such as Certified Quality Engineer (CQE) through American Society for Quality (ASQ).
Project management experience
Experience conducting statistical analysis using Minitab
Power BI experience
Experience conducting internal and external audits
Six Sigma Green or Black Belt training/certification
Post Market Analysis experience
Executing change management experience
Design reviews participation experience

Responsibilities

Assuming responsibility for initiating and performing defined quality activities leading to new or improved processes or systems on a program level.
Supporting failure investigations and problem resolution, assuming responsibility for initiating and performing defined quality activities.
Implementing quality engineering services for new and existing medical device products to ensure compliance with the quality system for all projects.
Participating in project planning.
Assisting in establishing project objectives and priorities.
Leading medium-sized teams.
Maintaining an awareness of quality improvement and product opportunities and being productive in suggesting and testing ideas.
Complying with corporate policies, procedures and security standards while performing assigned duties.