Senior Quality Engineer – Medical Device Manufacturing

Yoh, A Day & Zimmermann Company; Saint Paul (MN); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401K retirement plan

Paid time off

Job summary

Yoh Life Sciences in St. Paul, MN is seeking a Senior Quality Engineer to lead site-level quality initiatives in a medical device manufacturing setting. You will drive investigations, CAPA, risk assessments, and process validation activities, ensuring QMS compliance and cross-functional collaboration.

The role requires hands-on expertise in IQ/OQ/PQ, statistical methods, and leadership of quality teams. This onsite position offers direct-hire stability and opportunities for advancement within

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 7 years of progressive Quality Engineering or Quality Assurance experience in medical device or other regulated environments.
• Experience leading complex investigations, CAPA, nonconformance resolution, and validation activities.
• Strong knowledge of ISO 13485 and FDA QMS requirements; statistical quality tools.

Responsibilities

• Serve as a primary site-level Quality Engineering resource for manufacturing operations.
• Lead nonconformance investigations, CAPA, and risk management activities.
• Develop and review IQ/OQ/PQ validation protocols and reports.
• Apply SPC, Cp/Cpk, Gage R&R, DOE and statistical analyses.
• Mentor QC personnel and support audits and quality initiatives.

Skills

Quality engineering

CAPA investigations

Root cause analysis

IQ/OQ/PQ validation

GxP/regulatory compliance

DOE/ANOVA/ SPC

Cross-functional leadership

Statistical software (Minitab)

Education

Bachelor's degree in Engineering or Life Sciences

Tools

IQ/OQ/PQ validation tools

Job description

Senior Quality Engineer - Medical Device Manufacturing

Location: St. Paul, MN (100% Onsite)
Employment Type: Direct Hire | Full-Time
Salary: $100,000-$120,000 annually, depending on experience
Schedule: Monday-Friday

Position Overview

Yoh Life Sciences is seeking an experienced Senior Quality Engineer for a direct-hire opportunity with an established manufacturing organization in St. Paul, Minnesota.

This position will serve as a primary Quality Engineering resource at the Minnesota manufacturing site, providing technical leadership across manufacturing operations, process validation, investigations, risk management, and continuous improvement initiatives.

The ideal candidate brings extensive experience in regulated manufacturing environments, demonstrates the ability to independently resolve complex quality challenges, and has the communication and leadership skills to influence cross-functional teams.

This is an excellent opportunity for a seasoned Quality Engineer interested in taking ownership of site-level quality initiatives and developing toward future quality management responsibilities.

Key Responsibilities

• Serve as a primary site-level Quality Engineering resource, providing independent technical guidance and quality oversight for manufacturing operations.
• Lead complex nonconformance investigations, CAPA activities, complaint investigations, root cause analysis, and effectiveness verification through closure.
• Independently develop, execute, and review manufacturing process and equipment validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Establish validation strategies, acceptance criteria, sampling plans, statistical rationales, and challenge conditions to demonstrate process capability and compliance.
• Apply statistical quality engineering methods, including SPC, Cp/Cpk, Gage R&R, Design of Experiments (DOE), ANOVA, hypothesis testing, and process capability analysis.
• Lead risk assessments, including FMEA/PFMEA, and implement appropriate risk mitigation and process controls.
• Evaluate nonconforming materials, support risk-based disposition decisions, and ensure appropriate containment and corrective actions.
• Support manufacturing process improvements, equipment changes, engineering change control, and implementation of quality-related initiatives.
• Partner closely with Manufacturing, Engineering, Operations, and Quality Control to troubleshoot production issues and improve product quality, process reliability, and manufacturing performance.
• Develop and maintain validation protocols, reports, investigations, technical justifications, and other quality documentation in accordance with regulatory requirements.
• Support internal, customer, and supplier audits, providing technical explanations and defending quality decisions when necessary.
• Provide technical guidance and mentorship to Quality Control personnel and other cross-functional team members.
• Identify and escape significant quality risks while independently managing competing priorities and driving timely resolution.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Minimum 7 years of progressive Quality Engineering or Quality Assurance experience in medical device, biotechnology, pharmaceutical, or other regulated manufacturing environments.
• Demonstrated experience independently leading complex manufacturing quality investigations, CAPA, nonconformance resolution, and validation activities.
• Hands-on experience developing and executing manufacturing process and equipment validation protocols, including IQ/OQ/PQ.
• Strong working knowledge of ISO 13485, applicable FDA 21 CFR Part 820/QMSR requirements, and risk-based quality management principles.
• Advanced understanding and practical application of statistical quality engineering tools and methodologies, including Minitab or equivalent software, SPC, Cp/Cpk, Gage R&R, DOE, and statistical sampling.
• Experience applying root cause analysis, risk management, process FMEA, and corrective/preventive action methodologies in manufacturing environments.
• Demonstrated ability to work independently, make sound technical decisions, and manage complex quality initiatives with minimal supervision.
• Strong written and verbal communication skills, including the ability to present technical findings, influence cross-functional stakeholders, and communicate effectively with manufacturing leadership.
• Demonstrated leadership capabilities through technical project ownership, cross-functional initiatives, mentoring, or similar responsibilities.
• Ability to work onsite in St. Paul, Minnesota.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or Lean Six Sigma Green Belt certification.
• Experience with medical device manufacturing processes, equipment qualification, and manufacturing process controls.
• Familiarity with ISO 14971 risk management principles and PFMEA/control plan development.
• Experience with electronic quality management systems such as uniPoint, TrackWise, or Arena.
• Experience with sterilization processes, including ethylene oxide (EO) or gamma sterilization.
• Familiarity with cleanroom manufacturing, sealing equipment, environmental controls, DI water systems, or HVAC qualification.
• Experience mentoring quality personnel or preparing for increased site-level quality leadership responsibilities.

Compensation & Opportunity

• Annual base salary: $100,000-$120,000, depending on qualifications and experience.
• Direct-hire, full-time opportunity.
• Onsite position in St. Paul, Minnesota.
• Opportunity to serve as a key technical Quality Engineering resource with potential for future advancement into quality management.

Work Authorization

Applicants must be authorized to work in the United States without employer sponsorship now or in the future. The employer is unable to provide immigration sponsorship or related work authorization support.

Yoh Life Sciences is an Equal Opportunity Employer.

Estimated Min Rate: $100000.00

Estimated Max Rate: $120000.00

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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