Quality Engineer

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The Quality Engineer plays a key role in maintaining and enhancing the Quality Systems at our Madison, WI manufacturing facility. This position involves a broad range of responsibilities including conducting product complaint investigations, performing root cause analyses (RCA), developing and maintaining manufacturing quality processes, and managing quality-related data and trends. Additional duties include investigating deviations, overseeing CAPA and change control processes, supporting internal and external audits, and managing supplier quality. The Quality Engineer will collaborate closely with teams across Operations, Technical Operations, Engineering, and Materials Management to promote and strengthen a culture of quality throughout the organization.

• Perform trending and analysis of customer complaint data

• Drive investigations and manage deviations and NCMRs from initiation to disposition

• Perform and lead RCAs through cross functional team involvement

• Support the development and maintenance of manufacturing quality control processes for new and existing production areas

• Support supplier quality management with respect to desk audit and quality agreement creation, execution and review via direct customer contact

• Maintain process Failure Mode and Effects Analysis for new and existing production areas

• Manage CAPA creation and ensure adequate effectiveness

• Improve existing procedures to align with cGMP and regulatory requirements

• Interpret and properly apply all applicable regulatory requirements

• Improve quality culture through site initiatives

• Review and approval of procedures, protocols, reports, etc., as required.

• Perform internal and external audits of systems and suppliers

• Filing and management of documentation when required

• Supporting other Quality System Functions

• Bachelor’s degree in Engineering, Science, or a related technical field

• 3+ years’ experience in a cGMP-regulated Quality Assurance or Compliance environment

• Strong working knowledge of cGMPs and experience supporting regulatory inspections

• Moderate proficiency in statistical analysis and data interpretation

• Proven ability to lead through change, work independently, and make sound decisions using critical thinking

• Effective communication, presentation, mentoring, and technical writing skills

• Demonstrated leadership, emotional intelligence, strong project management and organizational abilities

• Proficient in Microsoft Office tools, particularly Excel, Word, and PowerPoint

• Willingness to travel 5–10%

Preferences:

• Experience with Medical Device manufacturing

• Experience with Minitab or equivalent statistical software

• ASQ certification

The Quality Engineer collaborates closely with Manufacturing, Engineering, Quality Control, Facilities, Materials Management, Regulatory Affairs, Maintenance/Metrology, and site external entities (Distribution Operations, Customer Care, Quality Compliance, etc.). The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Quality Assurance Manager.  It is the expectation this position works during normal business hours M-F, but work may be performed outside normal business hours when required to support business needs.

The Quality Engineer will mainly work in an office environment but may also be required to work in manufacturing, warehousing, and laboratory areas.

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