Quality Engineer

Yoh, A Day & Zimmermann Company; Saint Paul (MN); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account

Life & Disability Insurance

401K Retirement Savings Plan

EAP

Certification and training

Job summary

Yoh, A Day & Zimmermann Company is hiring a Quality Engineer in Saint Paul, MN to support medical device manufacturing operations. You will resolve technical quality issues, drive process improvements, and apply ISO 14971 principles to risk management and validations as needed.

The successful candidate brings hands-on IQ/OQ/PQ validation, FMEA, CAPA experience, and strong statistical analysis skills using Minitab.

Qualifications

• 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 820, 210, 211) and ISO 13485.
• Knowledge of process and equipment validation methods (IQ/OQ/PQ).
• Knowledge of statistical analysis and Minitab (process capability, normality, hypothesis testing, ANOVA, sampling, DOE).
• Experience supporting manufacturing quality investigations, risk assessments, CAPA, and validation activities.
• Strong technical writing skills for validation protocols, reports, and documentation.
• Ability to work independently and communicate across departments.

Responsibilities

• Plan, execute, and document process and equipment validations (IQ/OQ/PQ).
• Develop validation protocols, establish acceptance criteria, analyze results, and prepare technical reports.
• Support risk assessments, FMEA, CAPA, and quality investigations.
• Analyze manufacturing quality data using statistical methods to support decisions and improvements.
• Collaborate with manufacturing and engineering to investigate issues and implement improvements.
• Support QMS activities including complaint analysis, risk assessments, and verifications/validations.
• Monitor processes and quality metrics to ensure regulatory compliance.
• Maintain validation records and technical documentation per QMS requirements.

Skills

Quality assurance

Statistical analysis

Problem solving

Communication

Independent work

Education

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

Tools

Minitab

SPC

DOE

GRR

IQ/OQ/PQ validation

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: $80000.00

Estimated Max Rate: $90000.00

What's In It for You?

• 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. All qualified applicants are welcome to apply.

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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