Quality Engineer

Job Description

Job Description

Job Title: Quality Engineer

Job Description

The Quality Engineer develops and improves manufacturing processes and products, validates new equipment and technologies, and drives continuous improvement on the shop floor. This role 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 works closely with QA Technicians and Quality Inspectors to maintain robust quality systems and support production in achieving operational objectives.

Responsibilities

• Develop new manufacturing processes and products and revise existing ones to meet customer and regulatory requirements.
• Create, update, and maintain project-specific quality plans that align with customer specifications and internal standards.
• Collaborate as part of a cross-functional team to support process and product development initiatives.
• Develop and refine measurement methods to ensure products meet defined quality 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.
• Collaborate with customers and suppliers on new product and process introductions to ensure quality expectations are met.
• Lead the management of customer complaints and supplier SCARs, ensuring timely and effective resolution.
• Compile and analyze statistical data to assess process capabilities and drive data-based decisions.
• Plan and conduct PFMEA, GR&R, and SPC studies to identify and mitigate risks and improve process performance.
• Create and maintain quality system documentation, including quality plans, inspection and 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 while ensuring compliance with customer agreements, ISO standards, and internal requirements.
• Prepare, submit, and follow up on change requests (SCRs) with customers, ensuring clear communication and approval.
• Assist production teams in achieving APU objectives by providing quality engineering support and guidance.
• Generate and report quality KPIs for PSM2 to monitor performance and drive continuous improvement.
• Perform internal and external audits to verify compliance with quality system requirements and identify improvement opportunities.
• Support continuous improvement initiatives across the manufacturing environment, focusing on quality, efficiency, and cost optimization.

Essential Skills

• Bachelors degree in Manufacturing Engineering or a related field.
• Minimum of two years of relevant experience in quality engineering or a closely related discipline (five years for a sr-level position).
• Demonstrated experience in quality engineering within a regulated environment, such as medical devices.
• Proficiency in process and product development in a manufacturing setting.
• Proven experience developing manufacturing quality plans.
• Experience conducting process capability studies and statistical analysis.
• Hands-on experience with GR&R, PFMEA, and SPC studies.
• Experience working with NCRs and CAPAs, including root cause analysis and corrective and preventive actions.
• Knowledge in quality assurance and quality management within an ISO environment, preferably ISO standards relevant to medical devices.
• Strong skills in root cause analysis, CAPA management, and nonconformance management.
• Ability to drive continuous improvement and process improvement initiatives.
• Strong blueprint reading skills with a solid understanding of GD&T.
• Ability to work effectively in cross-functional teams and communicate with customers and suppliers.
• Familiarity with validation activities, including IQ, OQ, and PQ for products and equipment.

Additional Skills & Qualifications

• Experience in a precision machine shop environment.
• Experience optimizing manufacturing processes to achieve ongoing cost reductions.
• LEAN and/or Six Sigma training with demonstrated practical application.
• Demonstrated use of structured problem-solving methods such as 8D.
• Experience performing internal and supplier audits.
• Experience using an ERP system to support quality and production activities.
• Exposure to FDA-regulated environments or similar highly regulated industries.
• Strong analytical and statistical skills for data-driven decision making.
• Effective communication skills for interfacing with production teams, customers, and suppliers.

Work Environment

This role is fully onsite at a manufacturing facility in Coon Rapids, MN. The environment is a clean production setting focused on the manufacture of precision instruments and implants for advanced surgical applications, including robotic and minimally invasive procedures. The position operates on a standard 40-hour workweek, with flexible start and stop times generally within the 9:00 a.m. to 5:00 p.m. timeframe. Team members work closely with cross-functional groups, including production, engineering, and quality, using modern manufacturing and quality tools, validation methods, and ERP systems. The company culture emphasizes innovation, continuous improvement, and a shared commitment to improving patients quality of life. Business casual attire is expected in this environment.

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 companys 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 Permanent position based out of Coon Rapids, MN.

This position is anticipated to close on Nov 3, 2026.

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

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 View email address on ziprecruiter.com 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.