Quality Engineer (Onsite - Columbia, MO)

Solventum•Columbia, MO

2d•Onsite

About The Position

Solventum, a new healthcare company with a long legacy of solving big challenges, is seeking a Quality Engineer. At Solventum, people are at the heart of every innovation. The company partners with the brightest minds in healthcare to create solutions that meld the latest technology with compassion and empathy. This role enables better, smarter, safer healthcare to improve lives by pioneering game-changing innovations at the intersection of health, material, and data science. The Quality Engineer will provide product assurance engineering support for commercialized products, participate in various audits, ensure quality assurance and control for FDA-regulated products, collaborate with manufacturing engineers to resolve quality issues, lead investigations for nonconforming materials and complaints, and drive quality improvement using engineering best practices and methodologies.

Requirements

Bachelor’s Degree or higher in an engineering or science discipline (completed and verified prior to start)
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.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

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

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.
Complying with corporate policies, procedures and security standards while performing assigned duties.