Director of Product Quality

Country United States Shift 1st About the Position Werfen is a global company focused on specialized diagnostics in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. The role is located in the US. 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, 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. Play a critical role in strengthening root cause analysis, improving CAPA effectiveness, and building organizational capability in structured problem solving. Build high‑performing teams with clear accountability, strong technical capability, and a continuous improvement mindset. Establish effective goals, metrics, and operating mechanisms for the Product Quality function. Partner closely with Manufacturing, R&D, Operations, Supply Chain, and site Quality leadership to drive quality performance and business results. Lead continuous improvement initiatives that translate data insights into sustainable operational gains leveraging statistical analysis and advanced quality tools. Champion the use of appropriate analytical and statistical techniques across the organization to support informed decision making, root cause analysis, and proactive risk mitigation. Lead cross‑functional, high‑impact quality initiatives, providing deep technical guidance and ensuring alignment between quality objectives and broader business goals. Drive 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 management 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 experience 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 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, scatter 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 consistent 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. 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. 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