Apply on Employer Site

Solventum · 7 hours ago

Quality Engineer (Onsite - Columbia, MO)

Columbia, MO

Full-time

Onsite

Mid Level

$96K/yr - $117K/yr

3+ years exp

Solventum is a new healthcare company focused on solving significant challenges in the healthcare sector. As a Quality Engineer, you will provide product assurance engineering support, lead audits, and drive quality improvements while collaborating with diverse teams.

Medical Device

No H1B

Responsibilities

Providing product assurance engineering support for commercialized products including specification and design control, change management, risk management, investigations, and continuous improvement

Reviewing and approving IQ/OQ/PQ documents and validation documents to qualify and validate new equipment and processes

Participating in and leading 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

Qualification

Quality SystemsISO-13485Statistical TechniquesRoot Cause AnalysisCQE CertificationEngineering DegreeEngineering ExperienceCuriosityOrganizationResilienceMS Office ProficiencyCommunication SkillsCollaboration

Required

Bachelor's Degree or higher (completed and verified) from an accredited institution

Preferred

Bachelor's degree or higher in Manufacturing/Industrial Engineering, Chemical Engineering, Mechanical Engineering, Statistics/Mathematics from an accredited institution

Three (3) years of engineering experience in a private, public, government or military environment

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