Quality Engineer

Job Description

Job Description

Job Title: Quality Engineer Job Description

The Quality Engineer evaluates and investigates product complaints and nonconformances, drives corrective and preventive actions, and supports new product introduction to ensure consistent compliance with quality standards. This role serves as a key liaison between the plant, customers, and internal teams, authoring and maintaining quality system documentation, performing internal audits, and promoting continual improvement in processes and product design within a regulated manufacturing environment.

• Perform and document evaluations and investigations resulting from customer complaints, product nonconformances, and corrective and preventive actions (CAPA).
• Deploy formal root cause analysis methods and tools to identify underlying issues and implement effective corrective actions.
• Validate and approve Production Part Approval Process (PPAP) submissions for new product introduction (NPI) programs.
• Serve as a representative of the plant to customers, providing professional communication and support on quality-related topics.
• Collaborate with cross-functional internal groups to respond to product inquiries, resolve issues, and support continuous improvement initiatives.
• Disposition returned products in accordance with established procedures and quality system requirements.
• Perform internal audits in accordance with ISO 9001 and other applicable quality standards to ensure ongoing compliance.
• Ensure continual improvement in process and product design by identifying opportunities, recommending changes, and supporting implementation.
• Participate in customer audits and notified body audits, providing documentation, explanations, and follow-up actions as needed.
• Author and maintain quality management system (QMS) documents, specifications, and work instructions that meet and sustain quality standards.
• Track plant performance against quality requirements using established measurement standards and metrics.
• Verify the effectiveness of CAPA actions by reviewing data, monitoring outcomes, and updating records.
• Interact with customers in a professional manner to address quality concerns, provide status updates, and support long-term relationships.
• Support process validation, advanced product quality planning (APQP), and related activities for new product development and ongoing production.
• Contribute to a culture of quality and continuous improvement within a manufacturing environment, particularly for medical and electro-mechanical products.

• 1–3 years of experience in a quality or regulatory affairs role.
• Hands-on ownership of CAPA activities, including investigation, implementation, and verification of effectiveness.
• Strong root cause analysis skills using formal methodologies and tools.
• Experience with internal auditing, preferably to ISO 9001 or similar quality management system standards.
• Experience with complaint and nonconformance management in a manufacturing environment.
• Familiarity with PPAP and APQP processes for new product introduction and ongoing production.
• Exposure to medical device or GMP-related industries, with understanding of regulated quality systems.
• Knowledge of process validation in a manufacturing or product development context.
• Proficiency with Microsoft Office Suite (such as Word, Excel, and PowerPoint) for documentation and reporting.
• Strong organizational skills with the ability to manage multiple tasks and priorities.
• Strong problem-solving skills with a quality- and results-oriented mindset.
• Ability to interact with customers in a professional and collaborative manner.
• Comfort working in or around production environments within a manufacturing facility.

• Knowledge of GMP-related industries is preferred.
• Experience with quality system standards, including ISO 9001, is preferred.
• ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) certification is preferred.
• Experience in a medical device or healthcare-related manufacturing environment is an advantage.
• Familiarity with electro-mechanical products, such as surgical medical carts, is beneficial.
• Exposure to new product development processes and cross-functional collaboration.
• Strong written communication skills for authoring QMS documents, specifications, and work instructions.
• Ability to work effectively in a growing organization undergoing investment and expansion.

The role is based in a standard office environment with regular visits to production areas. Production areas may be hot, cool, or dusty and have a moderate noise level, reflecting an active manufacturing setting. The organization is undergoing significant investment and growth, expanding into more electro-mechanical products, including surgical medical carts. Team members work with a mix of office technology and manufacturing equipment, collaborating closely with production, engineering, and quality teams in a dynamic, improvement-focused culture.

This is a Permanent position based out of Milwaukee, WI.

The pay range for this position is $90000.00 - $100000.00/yr.

401k Dental, Health, Vision

This is a fully onsite position in Milwaukee,WI.

This position is anticipated to close on Aug 17, 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment 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 the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: 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.

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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.