Company Summary: A leading medical device company is looking for a seasoned and ambitious leader to join its team as the Director of Quality. With their products far outperforming the competition, it is no surprise they hold a majority of the market share of the industry. Projections show them growing to a 2 billion dollar company by 2028, and a 4 billion dollar company over the next 10 years.

ESSENTIAL DUTIES

• Ensure timely recruitment of skilled and experienced team members to support factory ramp-up.
• Oversee site validation activities for new lines and process improvements.
• Manage supplier and receiving quality assurance to guarantee that tooling/equipment validations meet production volume commitments and address non-conformances promptly.
• Collaborate with R&D to align product and material specifications with customer needs and manufacturability.
• Identify gaps in the Quality Management System (QMS) and strengthen it by updating procedures and policies to mitigate risks to product supply and quality.
• Partner with the site operational excellence leader to develop daily metrics and operating mechanisms to improve Non-Conformance/Corrective and Preventive Actions (NC/CAPA) processes, validation, defect frequency, and other key quality and supply metrics.
• Maintain a strong GEMBA orientation and promote a culture of accountability and continuous improvement.
• Address customer issues by resolving product, procedure, and policy problems, implementing significant process or system changes as needed.
• Collaborate with site and global teams to support product complaint investigations, NCs, or CAPAs, ensuring product conformity and reducing complaints.
• Ensure thorough root-cause investigations and resolutions to prevent recurring product quality issues.
• Develop and maintain constructive relationships with customers, operations, and other business/regional/functional entities.
• Simplify problems and develop solutions to eliminate issues and improve cross-functional relationships and processes.
• Facilitate the sharing of best practices across the company.
• Work with internal and external resources to resolve complex and sensitive issues, often representing operations or the quality group on projects or management teams.
• Collaborate with global and external resources to manage responsibilities, including Operations, R&D, etc.
• Demonstrate knowledge and skills in QMS/cGMP requirements, including those for medical devices and combination products.
• Implement QMS to support certification by regulatory bodies.
• Develop, report, and improve on QMS-related metrics.
• Ensure audit and inspection readiness at all times.
• Influence and drive teams in process improvements, trend monitoring, correlating leading quality metrics, problem-solving approaches, and data analysis. Lead root cause analysis of complex systems issues.
• Evaluate product changes, ensuring a full understanding of their implications.
• Lead Management Reviews to drive cross-functional involvement and continuous improvement.
• Continuously analyze changing business and customer needs, proposing organizational or systems changes to address them and recommending improvements to other areas.
• Oversee factory complaint investigation processes, internal audit processes, and CAPA processes. Collaborate with manufacturing, engineering, and other groups on regulatory compliance issues.
• Develop solutions to moderate to high complexity problems, interpret, execute, and recommend modifications to operating policies as appropriate.
• Serve as the Management Representative for FDA responsibilities, holding the plant manager accountable for the role with executive responsibility.
• Foster a culture that reflects core values and quality principles, ensuring continuous development of associates.
• Provide effective formal training and professional skill development for associates.
• Promote associate development through participation in cross-functional teams.
• Manage budget development and management for areas of responsibility.
• Recruit, select, train, appraise performance, and administer salaries for reporting employees; determine assignments and change employee status in accordance with company policy.
• Ensure compliance with the Code of Conduct and appropriate business controls.
• Address business process issues and priorities, managing resources effectively to resolve process, procedure, and policy problems, driving necessary changes to meet customer and business needs.
• Influence short- and long-term business goals and operating policy, impacting corporate objectives and long-range goals related to QMS and compliance.
• Support factory ramp-up by timely filling critical headcount.

MINIMUM QUALIFICATION REQUIREMENTS

Education:

• Bachelor's degree in Quality or a STEM-related discipline with 10 years of experience, including 5 years of management experience, or a Master's degree in a related discipline.

Knowledge and Experience:

• 10 years of experience with 5 years in management, or an equivalent combination of education and experience.
• 5 years of experience in a manufacturing environment with highly/fully automated processes, preferably in the medical device industry.
• Demonstrated QMS and audit expertise for medical devices and combination products, with knowledge of applicable standards (e.g., ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations).
• Extensive knowledge of U.S. and international medical device regulations and standards.
• Understanding of quality management requirements and experience in developing quality goals and measures, and directing others, including R&D, suppliers, and process engineering.

Skills:

• Proven leadership and team development skills, with the ability to build and maintain effective relationships across functions and organizational levels.
• Expertise in planning, budgeting, personnel development, and project management to achieve short- and long-term business plans and goals.
• Knowledge and application of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
• Strong interpersonal skills, capable of interfacing with senior management and interacting with diplomacy and tact while maintaining assertiveness and persistence.
• Positive, proactive problem-solving approach, mentoring others to model this behavior, and motivating teams to find solutions.
• Ability to diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
• Thorough understanding of customer satisfaction measures and experience in their implementation for continuous improvement.
• Essential cultural and situational flexibility and adaptability.