Director of Product Quality

• 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 leadership to drive quality performance and business results
• Leads continuous improvement initiatives that translate data insights into sustainable operational 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 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

• 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
• ASQ Certified Quality Engineer required
• 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 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

• ASQ Certified Six Sigma Black Belt preferred
• Experience with sterilization programs and stability programs preferred

Bonus-eligible position