Quality Engineer

Job Title: Quality Engineer

Job Description

The Quality Engineer plays a key role in developing and improving manufacturing processes and products, validating new equipment and technologies, and driving continuous improvement on the shop floor. This position manages customer complaints and CAPA/NCR activities, leads change requests with customers, and ensures compliance with ISO, FDA, and other applicable standards. The Quality Engineer collaborates closely with QA Technicians and Quality Inspectors to maintain high-quality output in a regulated medical device environment.

Responsibilities

• Develop new manufacturing processes and products and revise existing ones to meet customer and regulatory requirements.
• Create and update project-specific quality plans that ensure adherence to customer specifications and quality standards.
• Work as part of cross-functional teams to support process and product development initiatives.
• Develop methods to measure products and verify that they meet defined quality and performance standards.
• Troubleshoot measurement methods and equipment to ensure accuracy, reliability, and repeatability.
• Lead validation activities for new products and technologies, including IQ, OQ, and PQ phases.
• Serve as the QA lead for equipment validation, ensuring proper documentation and compliance with quality system requirements.
• Collaborate with customers and suppliers on new product processes and quality expectations.
• Lead the management of customer complaints and supplier SCARs, ensuring timely resolution and preventive actions.
• Compile and analyze statistical data to assess process capabilities and identify opportunities for improvement.
• Conduct PFMEA, GR&R, and SPC studies to evaluate and control process risks and variability.
• Create and maintain quality system documentation, including quality plans, inspection plans, control plans, and work instructions.
• Manage NCRs, CAPAs, and customer complaints from creation through closure, using structured problem-solving tools.
• Lead changes in production processes, ensuring compliance with customer agreements, ISO standards, and internal requirements.
• Prepare, submit, and follow through on change requests (SCR) with customers to obtain approvals for process or product changes.
• Assist production teams in achieving APU objectives by providing quality engineering support and guidance.
• Generate quality KPIs for PSM2 and other performance dashboards to monitor and communicate quality performance.
• Perform internal and external audits to verify compliance with quality system requirements and regulatory standards.
• Drive continuous improvement initiatives focused on process optimization, cost reduction, and enhanced product quality.
• Support and reinforce a strong quality culture focused on improving the quality of life of patients through reliable medical device products.

Essential Skills

• Minimum of two years of relevant quality engineering experience in a regulated manufacturing environment; five years for sr-level consideration.
• Bachelor’s degree in Manufacturing Engineering or a related field.
• Hands-on experience in quality engineering, including process and product development.
• Demonstrated experience working in a regulated environment, such as medical devices, with exposure to FDA and ISO requirements.
• Proficiency in CAPA and nonconformance management, including root cause analysis and corrective and preventive actions.
• Strong experience in quality assurance and quality management principles.
• Proven ability to drive continuous improvement and process improvement initiatives on the shop floor.
• Experience developing manufacturing quality plans that align with customer and regulatory requirements.
• Experience conducting process capability studies and using statistical tools to evaluate process performance.
• Demonstrated experience performing GR&R, PFMEA, and SPC studies.
• Experience working with NCRs and CAPAs from initiation through closure.
• Experience working in an ISO environment, preferably ISO-compliant medical device manufacturing.
• Mandatory blueprint reading skills with a strong understanding of GD&T.
• Ability to use structured problem-solving tools and methodologies to resolve quality issues.
• Strong analytical skills with the ability to interpret statistical data and make data-driven decisions.
• Effective communication skills for interfacing with production teams, QA staff, customers, and suppliers.
• Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously.

Additional Skills & Qualifications

• Experience in a precision machine shop environment, particularly related to implants and instruments for minimally invasive, orthopedic, spinal, or traumatological surgery.
• Experience optimizing manufacturing processes to achieve ongoing cost reductions while maintaining or improving quality.
• LEAN or Six Sigma training with demonstrated application in a manufacturing or quality engineering context.
• Demonstrated use of structured problem-solving methods such as 8D.
• Experience conducting internal and supplier audits to assess compliance and drive improvements.
• Experience using an ERP system to support quality and production activities.
• Familiarity with instruments for robotic surgery and osteosynthesis implants is beneficial.
• Ability to thrive in a clean, high-precision production environment focused on medical devices.
• Strong commitment to improving the quality of life of patients through high-quality products and processes.

Work Environment

This role is fully onsite at a production facility in Coon Rapids, MN, within a clean, medical device manufacturing environment focused on implants and instruments for minimally invasive, orthopedic, spinal, and traumatological surgery, as well as instruments for robotic surgery and osteosynthesis implants. The facility is part of a larger global organization with multiple production sites and a strong culture of innovation and quality. Work hours are typically around the 9:00 AM to 5:00 PM timeframe, totaling approximately 40 hours per week, with some flexibility in start and stop times. The environment emphasizes collaboration between engineering, quality, and production teams, and uses modern manufacturing and quality systems, including ERP and statistical tools, to support operations. Business casual attire is expected. The organization offers an excellent benefits and compensation package and promotes a strong company culture centered on supporting clients and improving the quality of life of patients.

This is a Permanent position based out of Coon Rapids, MN.

The pay range for this position is $80000.00 - $100000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Employees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life/AD&D insurance, and the company’s 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees. Full-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time.

This is a fully onsite position in Coon Rapids,MN.

This position is anticipated to close on Oct 2, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.