Quality Engineer - Systems Assurance
On-siteWaukesha, Wisconsin, United States
Job Summary
Oversee end-to-end CAPA processes, ensuring timely identification, investigation, and closure of corrective and preventive actions. Manage customer complaint investigations and resolutions, coordinating cross-functional teams to ensure MDR/IVDR and FDA 21 CFR 803 compliance for reportable events. Serve as a Subject Matter Expert during regulatory audits and inspections while maintaining compliant metrics for management review. Drive continuous improvement initiatives to optimize efficiency and compliance across domestic and international departments. Support other Quality Management Systems including supplier management, risk management, and change control. Requires a Bachelor's degree in Engineering or Life Sciences with 7+ years in medical device CAPA and complaint handling. Full-time role with 5% or less annual travel.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, and/or related fields
- Minimum 7 years of experience in medical device, pharmaceutical, or biotechnology industries with a focus on CAPA and complaint handling
- Strong understanding of FDA 21 CFR 820, ISO 13485, EU MDR, and global quality system regulations
- Expertise in CAPA investigations, root cause analysis (RCA), and risk management (ISO 14971)
- Experience with electronic QMS (eQMS) systems (e.g.,TrackWise, MasterControl, SAP)
- Strong analytical, communication, and leadership skills
- Excellent verbal and written communication skills
- Exhibits a disciplined approach to work ensuring thoroughness, consistency, validation, and accuracy in all tasks and work product
- 5% or less annually travel
Desired Qualifications
- Master's degree preferred
- Preferably direct experience with IVD's for HLA screening, and ELISA products
- Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement
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