Quality Engineer – Onsite in Columbia, MO

Solventum in; Columbia Township (MO); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Health Savings Accounts

Health Care & Dependent Care Flexible

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences

Retirement Benefits

Job summary

Solventum is seeking a Quality Engineer to join our onsite team in Columbia, MO. You will provide product assurance for commercialized products, participate in audits, and drive quality improvements using lean six sigma and statistical methods.

The role requires a Bachelor's degree in engineering or science, knowledge of ISO 13485 and FDA quality systems, and collaboration with manufacturing engineers to resolve issues. Travel is up to 5% domestically.

Qualifications

• Bachelor's Degree or higher in engineering or science discipline (completed and verified prior to start)
• 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 CQE certification or willingness to obtain
• Proficiency in statistical and quality engineering tools (EDA, statistics, Gage R&R, ANOVA, FMEA, SPC, capability, sampling, regression, experimental design)
• Excellent verbal and written communication skills
• Proficient in MS Office and data querying/analysis
• Strong organization, resilience, collaboration and curiosity

Responsibilities

• Provide product assurance engineering support for commercialized products including specification and design control, change management, risk management, investigations, and continuous improvement
• Participate in customer audits, ISO-9001, ISO-13485, internal audits and other activities to identify improvement opportunities
• Provide quality assurance and control for FDA-regulated products, including incoming materials control and review of tests and device history records
• Work with manufacturing engineers to solve product quality issues
• Lead investigations, corrective actions, trending, and monitoring for nonconforming materials and supplier issues
• Interact with division quality personnel and outside suppliers to ensure product quality and performance
• Drive quality improvement using engineering best practice and Lean Six Sigma methodologies

Skills

Root cause analysis

Communication skills

Collaboration

Curiosity

Organizational skills

Education

Bachelor's degree or higher in engineering or science

Tools

Quality manuals

ISO-13485

21 CFR Part 210/211/820

Metrology & calibration

Auditing

Supplier management

Gage R&R

ANOVA

FMEA

SPC & capability

Acceptance sampling

Correlation & regression

Experimental design

MS Office (Word, Excel, PowerPoint, Access)

Job description

Solventum is seeking a Quality Engineer to join our onsite team in Columbia, MO. You will provide product assurance for commercialized products, participate in audits, and drive quality improvements using lean six sigma and statistical methods.

The role requires a Bachelor's degree in engineering or science, knowledge of ISO 13485 and FDA quality systems, and collaboration with manufacturing engineers to resolve issues. Travel is up to 5% domestically.