Quality Engineer - Systems Assurance

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.

Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)

Key Accountabilities

CAPA Management:

• 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

Complaint Handling & Investigation:

• 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

Regulatory Compliance & Audits:

• 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 assignedeasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• Daily interaction with all departments domestic and international to support CAPA training and CAPA Closure.
• Interaction with Manufacturing Technical Support team in support of product investigations.
• Interaction with Research and Development to support product complaints and product improvements.
• Interaction with Quality Assurance for quality and regulatory compliance.
• Interaction with Customer Technical Support team in support of customer complaint investigation.

Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)

Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)

Minimum Knowledge & Experience required for the position:

• 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 complaint 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
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement                                                                        Skills & Capabilities:
• Effective communication
• Strong leadership
• Proactive problem-solving
• Stategic thinking
• Organizational skills and time management
• Coaching skills for improvement and problem solving
• Continous learning and development mindset
• Conflict resolution
• Foster a positive and inclusive work environmentTravel requirements:
• 5% or less annually

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com