Quality Engineer

Solventum•Us, CA

11d•Onsite

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. Solventum enables 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.

Requirements

Bachelor’s Degree or higher in engineering or science from an accredited institution and two (2) 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 (6) six years of Quality experience in a medical device and/or pharmaceutical company in a private, public, government or military environment
(1) one year experience with United States Food and Drug Administration (FDA) regulations and recognized quality standards, including ISO 14971

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.
Corporate policies, procedures and security standards are complied with while performing assigned duties.