Director of Product Quality

Introduction

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

 

The Director of Product Quality is responsible for leading the site Product Quality function, with primary accountability for Quality Engineering across both new product development and sustaining efforts, as well as Quality Control focusing on Incoming QC inspection, as well as Final QC inspection, and Quality Release activities. This role ensures robust quality support throughout the product lifecycle, from development through commercial manufacturing, with a strong focus on product and process quality, risk reduction, and effective problem solving.

 

The annual base salary range for this role is currently $200,000 to $240,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

 

Responsibilities

Key Accountabilities

• Lead, develop, and mentor the Product Quality organization, including Quality Engineering for new product and sustaining activities and Quality Control teams focusing on Incoming and QC Lab final Inspection, and Quality Release.
• Plays critical role in strengthening root cause analysis, improving CAPA effectiveness, and building organizational capability in structured problem solving.
• Builds high-performing teams with clear accountability, strong technical capability, and a continuous improvement mindset.
• Establishes effective goals, metrics, and operating mechanisms for the Product Quality function.
• Partners closely with Manufacturing, R&D, Operations, Supply Chain, and site Quality lea-dership to drive quality performance and business results.
• Leads continuous improvement initiatives that translate data insights into sustainable opera-tional gains leveraging statistical analysis and advanced quality tools.
• Champions the use of appropriate analytical and statistical techniques across the organization to support informed decision making, root cause analysis, and proactive risk mitigation.
• Leads cross functional, high impact quality initiatives, provides deep technical guidance, and ensures alignment between quality objectives and broader business goals.
• Drives continuous improvement initiatives for manufacturing processes, identifying and addressing quality issues through root cause analysis, corrective and preventive actions (CAPA), and statistical process control.
• Serve as the site’s subject matter expert on statistical tools and methodologies.
• Oversee the application of quality engineering principles in product design and development, including design controls, risk management, and design validation activities.
• Collaborate with Supply Chain and R&D to establish and maintain a robust supplier manage-ment program, including supplier selection, auditing, and performance monitoring.
• Ensure departmental and site wide activities are conducted in full compliance with applicable regulatory requirements, industry standards, and internal quality systems.
• Support internal and external audits.
• Work with Quality Leadership to establish priorities and goals for risk management, failure analysis, process validation, process capability, trend analysis, statistical quality control and process control.
• Serve as a point of contact for complex or high-risk quality issues and decisions.
• Identify and manage quality risks across the product life cycle, recommend and support mitigation strategies.
• Challenge the status quo and identify opportunities for improvement, chart the course for improvement actions, and take accountability for rigorous execution and delivery of improvement projects.

Networking/Key relationships

• Manufacturing/Operations
• Manufacturing Engineering
• Marketing
• Regulatory Affairs
• Research & Development
• Service
• Complaint Investigations

Qualifications

Minimum Knowledge & Experience for the position:

• Bachelor of Science degree required; Engineering degree preferred.
• Minimum of fifteen (15) years previous relevant work experience including in-depth experien-ce in quality engineering, and quality control required.
• Minimum of ten (10) years of previous supervisory experience required.
• In depth knowledge of relevant regulations in an ISO/FDA regulated company.

Skills & Capabilities:

• ASQ Certified Six Sigma Black Belt preferred.
• ASQ Certified Quality Engineer required.
• Experience with sterilization programs and stability programs preferred.
• Must possess a thorough understanding of process validation, software validation, and CAPA processes.
• Must be able to develop and deploy design of experiment tools/techniques.
• Must possess expert level knowledge of quality analysis tools/techniques such as Cause-and-effect diagrams, Pareto charts, run charts, scatters diagrams and regression analysis.
• Must possess an expert level knowledge of quality engineering principles including risk management, root cause investigation, and descriptive and inferential statistics.
• Must demonstrate excellent project management and problem-solving skills.
• Superior leadership abilities required.
• Superior planning, analytical, organizational and time management skills are required.
• Excellent communication and demonstrated negotiation abilities.
• Exhibits ability to accept and act on constructive criticism.
• Ability to create and continuously improve scalable and effective systems for ensuring consis-tent product quality and regulatory compliance.
• Ability to effectively champion the project task completion through constant interaction with peers and senior management in a professional manner.
• Ability to evaluate issues and new requirements in order to assess impact on the product and/or business.
• Ability to work effectively in a team-based organization, collaborate cross-functionally and globally with various technical & engineering-based groups, exercise influence at senior levels, and build alignment.

Travel requirements:Travel is limited to 15% or less.

Closing

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 NAtalentacquisition@werfen.com 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