Quality Engineer (Onsite - Columbia, MO)

SOLVENTUM • Columbia, MO

2d • Onsite

About The Position

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 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. Here, you will make an impact by: Providing product assurance engineering support for commercialized products including specification and design control, change management, risk management, investigations, and continuous improvement. Participating in customer audits, ISO 9001 audits, ISO 13485 audits, internal audits, and other activities to identify improvement opportunities. Providing quality assurance and control for products used in FDA regulated industries, including control of incoming materials, review of in-process tests and release tests and device history records. Working with manufacturing engineers and other personnel to solve product quality issues. Leading investigations, corrective action responses, trending and monitoring for nonconforming materials, complaints, and supplier issues. Interacting with Division quality personnel and outside suppliers to ensure product quality and performance. Driving quality improvement using engineering best practice, statistical techniques, and Lean Six Sigma methodologies.

Requirements

• Bachelor’s Degree or higher in an engineering or science discipline (completed and verified prior to start)

Nice To Haves

• Experience with quality systems such as Quality Manuals, ISO-13485, 21 CFR Part 210, 211 and 820, metrology, calibration, auditing and supplier management
• Working knowledge of root cause analysis tools and techniques
• American Society for Quality, Certified Quality Engineer (CQE) certification or willingness to obtain
• Proficiency in the use of statistical and quality engineering tools such as exploratory data analysis, basic statistics, Gage R&R, Analysis of Variance, Failure Modes and Effects Analysis, Statistical Process Control and Capability, acceptance sampling, correlation and regression, and experimental design
• Excellent verbal and written communication skills
• Proficient in MS Office (Word, Excel, PowerPoint, Access) and writing/using data queries, extracts and analysis
• Skills including organization, resilience, collaboration, and curiosity.

Responsibilities

• Providing product assurance engineering support for commercialized products including specification and design control, change management, risk management, investigations, and continuous improvement.
• Participating in customer audits, ISO 9001 audits, ISO 13485 audits, internal audits, and other activities to identify improvement opportunities.
• Providing quality assurance and control for products used in FDA regulated industries, including control of incoming materials, review of in-process tests and release tests and device history records.
• Working with manufacturing engineers and other personnel to solve product quality issues.
• Leading investigations, corrective action responses, trending and monitoring for nonconforming materials, complaints, and supplier issues.
• Interacting with Division quality personnel and outside suppliers to ensure product quality and performance.
• Driving quality improvement using engineering best practice, statistical techniques, and Lean Six Sigma methodologies.

Benefits

• Solventum offers many programs to help you live your best life – both physically and financially.
• To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
• Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level