Quality Engineer

Yoh; Saint Paul (MN); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training

Job summary

Yoh is seeking a Quality Engineer for our medical device client in Saint Paul, MN. You will support manufacturing operations, lead validations (IQ/OQ/PQ) and drive improvements in a regulated environment.

You will analyze quality data with Minitab, perform risk assessments, and contribute to FMEA, CAPA, and QMS activities while collaborating across engineering and manufacturing teams. The role requires a Bachelor's in engineering or life sciences and at least 3 years in medical device quality,

Qualifications

• Hands-on experience with process and equipment validation (IQ/OQ/PQ).
• Experience in manufacturing quality investigations and CAPA.
• Knowledge of FDA-regulated quality systems and ISO 13485.
• Strong statistical analysis skills using Minitab and DOE.

Responsibilities

• Plan, execute, and document process/equipment validations (IQ/OQ/PQ).
• Develop validation protocols, acceptance criteria, and technical reports.
• Support risk assessments, FMEA, CAPA, and quality investigations.
• Analyze manufacturing quality data using statistics to drive improvements.
• Collaborate with manufacturing/engineering to investigate issues and implement changes.
• Support QMS activities including complaint analysis and verification/validation.

Skills

IQ/OQ/PQ

Minitab

SPC

DOE

GRR

FMEA

CAPA

Statistical analysis

Education

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Tools

TrackWise

Arena

uniPoint

Job description

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

Job Functions

• 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.

Education, Licensure and/or Experience

• 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.

Preferred Qualifications

• 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 TrackWise, Arena, or uniPoint.
• Familiarity with medical device manufacturing equipment and environments, including sealers, cleanrooms, DI water systems, or HVAC systems.

Estimated Min Rate

$80,000.00

Estimated Max Rate

$90,000.00

What’s In It for You?

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

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