Quality Engineer (Onsite - Columbia, MO)

SOLVENTUM•Columbia, MO

56d•Onsite

About The Position

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. 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.

Requirements

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

Nice To Haves

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.

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.