Quality Engineer

Yoh is hiring a Quality Engineer for our client in Saint Paul, MN.

In this role, you will support medical device manufacturing operations, collaborate with cross-functional teams to resolve technical quality issues, and drive process improvements in a regulated environment. The ideal candidate is a motivated, independent Quality Engineer with hands‑on experience in process and equipment validation (IQ/OQ/PQ), manufacturing quality investigations, risk management, and statistical analysis. Experience applying ISO 14971 principles to process FMEA and validations is highly desirable.

Industry: Medical Device

Location:

Saint Paul, MN

Compensation: $80,000–$90,000 annually

Type:
Direct Hire

• Plan, execute, and document process and equipment validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop validation protocols, establish acceptance criteria, analyze results, and prepare technical summary reports.
• Support manufacturing risk assessments, Failure Mode and Effects Analysis (FMEA), Corrective and Preventive Actions (CAPA), and quality investigations.
• Collect, analyze, and present manufacturing quality data using statistical methods to support decision‑making and continuous improvement.
• Utilize quality engineering tools, including Minitab, Statistical Process Control (SPC), Design of Experiments (DOE), process capability studies, Gage Repeatability and Reproducibility (GRR), and trend analysis.
• Collaborate with manufacturing and engineering teams to investigate production issues, identify root causes, and implement process improvements.
• Support Quality Management System (QMS) activities, including complaint analysis, risk assessments, and process/equipment/software verification and validation.
• Monitor manufacturing processes, quality metrics, and product performance to ensure compliance with internal procedures and applicable regulatory standards.
• Maintain accurate technical documentation, validation records, and quality reports in accordance with established QMS requirements.

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 3 years of quality assurance experience in a medical device or pharmaceutical manufacturing environment.
• Experience with FDA‑regulated quality systems (21 CFR Part 820, 210, and/or 211, as applicable) and ISO 13485.
• Knowledge of process and equipment validation methodologies, including IQ/OQ/PQ.
• Knowledge of statistical analysis and Minitab, including process capability, normality assessments, hypothesis testing, ANOVA, sampling plans, and Design of Experiments (DOE).
• Experience supporting manufacturing quality investigations, risk assessments, and corrective and preventive actions.
• Strong technical writing skills, including the ability to develop and maintain validation protocols, technical reports, and quality documentation.
• Strong analytical, problem‑solving, and communication skills, with the ability to work independently and collaborate across multiple departments.
• Ability to manage multiple priorities in a fast‑paced manufacturing environment while maintaining accuracy and regulatory compliance.

• Experience applying ISO 14971 risk management principles to process FMEA and manufacturing validations.
• Hands‑on experience with Statistical Process Control (SPC) and Lean Six Sigma methodologies.
• ASQ Certified Quality Engineer (CQE) or equivalent quality certification.
• Experience with electronic QMS platforms such as Track Wise, Arena, or uni Point.
• Familiarity with medical device manufacturing equipment and environments, including sealers, clean rooms, DI water systems, or HVAC systems.

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