Quality Engineer - Systems Assurance

Werfen•Waukesha, WI

16h

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. The Quality Engineer - CAPA and Customer Complaint is responsible for overseeing corrective and preventive actions, managing customer complaints, and ensuring compliance with quality and regulatory standards. This role ensures that US Transplant Technololgy CAPA and complaint processes comply with FDA, ISO 13485, IVDR, and other global regulatory requirements while driving operational excellence.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Quality, and/or related fields; Master’s degree preferred
Minimum 7 years of experience in medical device, pharamaceutical, or biotechnology industries with a focus on CAPA and compliant handling. (Preferably direct experience with IVD’s for HLA screening, and ELISA products)
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

Nice To Haves

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement

Responsibilities

Oversee the end-to-end CAPA process, ensuring timely identification, investigation, and closure of corrective and preventive actions
Supports the review of root cause analyses (e.g., 5 Whys, Fishbone Diagrams, FMEA) to ensure proper and thorough investigations have been conducted and identify systemic issues
Ensure CAPA effectiveness checks are conducted and documented per regulatory requirements
Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices
Drive continuous improvement initiatives to optimize efficiency and compliance
Manage the customer complaint process; investigation, documentation and resolution
Coordinate cross-functional teams (Technical Support, Quality, Regulatory, and Manufacturing) to investigate complaints and implement corrective actions
Ensure MDR/IVDR and FDA 21 CFR 803 compliance for reportable events
Ensure CAPA and complaint processes align with FDA, ISO 13485, EU IVDR, and other global regulations
Serve as Subject Matter Expert (SME) during regulatory audits and inspections
Maintain compliant and CAPA metrics for Management Review and continuous improvement initiatives
Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices
Drive continuous improvement initiatives to optimize efficiency and compliance
Support other Quality Management Systems as required; applicable subsystems include, but are not limited to, supplier management, risk management and change control
Other duties as assigned