Staff Quality Engineering

Introduction

Werfen

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.

Overview

Job Summary

Bring your expertise in compliance, design controls, assay design, and system integration principles to the forefront of quality, science, and impact. As a Staff Quality Engineer within Werfen's Autoimmunity business, you will play a pivotal role in ensuring the safety, efficacy, and regulatory excellence of innovative IVD and medical device products. Partnering closely with R&D, Manufacturing, and cross‑functional leaders, you will help implement quality strategy across the full product lifecycle—from design and development through post‑market surveillance—while driving continuous improvement and influencing critical decisions. This is a highly visible individual‑contributor role for a seasoned quality professional who thrives on technical challenge, mentorship, and shaping robust, audit‑ready systems in a fast‑paced, evolving environment.

Responsibilities

Key Accountabilities

• Teamwork: Coordinate other functional areas of the company on design and development projects, product and process changes, risk management, root cause investigations, validations, process capability, trend analysis, and statistical process Develop, improve, implement, and maintain Quality Management procedures that ensure design and development, production, and post-production (post market) activities efficiently define, meet, and maintain customer, technical requirements, and regulatory requirements with objective evidence in accordance with applicable regulations and standards per company goals. Define and drive improvement projects and initiatives that reduce systemic manufacturing defects; improve quality systems.
• Product and Process Life Cycle: Represent Quality Engineering in Design and Development activities through launch, product and process changes, sustaining on-Market safety and efficacy, and post-market surveillance endeavors. Provide subject matter expertise and ensure the delivery of objective evidence using scientific methodology including technical validity, accuracy, completeness, and compliance to applicable regulations and standards in QMS areas such as product and process development, specification development, acceptance methods development, design transfer, design validation, process validation, risk management, product realization, packaging and shipping validation, product launch, and nonconformance assessment.
• Risk Management: Maintain QMS procedures that facilitate risk management activities and produce audit ready risk file documents in compliance with the requirements of current international risk management standards and regulations. 
• Quality Science and Engineering: Perform independent quality review and evaluation of change orders including related data for scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance to applicable regulations and standards. Provide guidance on identified gaps and collaborates to determine remediation activities. Apply critical analytical thinking in the investigation process specifically during root cause analysis, risk assessment evaluation and determination corrective and preventive actions determination to guarantee gaps are properly addressed. Provide consensed Quality input into process investigations using a systematic approach to ensure root causes and CAPAs are aligned. Collect and analyze defined quality metrics, quality-related data to identify issues or trends.
• Quality Management Systems: Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Aid in designing and documenting new and revised quality systems for product realization compliance with