Quality Engineer
Listed on 2026-07-18
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Quality Assurance - QA/QC
Quality Engineering, Production QC/QA, Quality Control - QC Analysts/Managers
Quality Engineer
The Quality Engineer supports and improves the quality management system by leading investigations into complaints and nonconformances, driving corrective and preventive actions, and ensuring compliance with ISO 9001 and related standards. This role validates and approves PPAPs for new product introduction programs, partners closely with internal teams and customers, and contributes to continuous improvement in process and product design within a manufacturing environment.
Responsibilities
- Perform and document evaluations and investigations resulting from complaints, nonconformances, and corrective and preventive actions (CAPA).
- Deploy formal root cause analysis methods and tools to identify and resolve underlying issues during investigations.
- Validate and approve Production Part Approval Process (PPAP) submissions for new product introduction (NPI) programs.
- Serve as a plant representative to customers, addressing quality-related inquiries and concerns in a professional manner.
- Collaborate with internal groups to respond promptly and effectively to product inquiries and issues.
- Disposition returned products in accordance with established procedures and quality requirements.
- Perform internal audits in accordance with ISO 9001 and applicable quality standards.
- Ensure continual improvement in process and product design by identifying opportunities and implementing quality enhancements.
- Participate in customer and notified body audits to demonstrate compliance with quality system standards.
- Author quality management system (QMS) documents, specifications, and work instructions that meet and maintain quality standards.
- Track plant performance against quality requirements using established measurement standards.
- Verify the effectiveness of CAPA activities and ensure that corrective actions prevent recurrence.
- Interact with customers in a professional, clear, and solutions-focused manner.
Essential Skills
- 1–3 years of experience in a quality or regulatory affairs role.
- Hands-on CAPA ownership and management experience.
- Root cause investigation expertise using formal problem-solving tools.
- Internal audit experience, preferably aligned with ISO 9001 standards.
- Experience with complaint and nonconformance management in a manufacturing environment.
- Exposure to and understanding of a manufacturing environment and its processes.
- Familiarity with quality management systems and their implementation.
- Proficiency with Microsoft Office Suite (such as Word, Excel, and PowerPoint).
- Strong organizational skills with the ability to manage multiple tasks and priorities.
- Strong problem-solving skills with a structured and analytical approach.
- Ability to interact with customers in a professional and confident manner.
Additional Skills & Qualifications
- Knowledge of Good Manufacturing Practice (GMP)–related industries is preferred.
- Experience with quality system standards beyond ISO 9001 is preferred.
- Experience with PPAP and Advanced Product Quality Planning (APQP) processes.
- ASQ Certified Quality Engineer or ASQ Certified Quality Auditor certification is preferred.
- Experience authoring QMS documents, specifications, and work instructions.
- Experience supporting customer or notified body audits.
- Interest in working with electro-mechanical products and medical-related applications, such as surgical medical carts.
Work Environment
This role operates primarily in a standard office environment with regular visits to production areas. Production areas may be hot, cool, or dusty and can have a moderate noise level. The organization is undergoing significant investment and growth, including expansion into more electro-mechanical products and surgical medical carts, offering opportunities to contribute to evolving processes, technologies, and quality practices.
Job Type & Location
This is a Permanent position based out of Milwaukee, WI.
Pay and Benefits
The pay range for this position is $90000.00 - $100000.00/yr. 401k Dental, Health, Vision
Workplace Type
This is a fully onsite position in Milwaukee, WI.
Final date to receive applications
This position is anticipated to close on Jul 24, 2026.
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