Design Assurance Quality Director

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion.

At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as our Design Assurance Quality Director, and you’ll do the same.

Your Key Responsibilities:

• Lead, mentor, coach, and develop a team of technical Quality Assurance professionals who collaborate with T&I on the design, development, and manufacturing transfer of new or changed medical device products.
• Ensure appropriate application of company policies and procedures for product development, risk management, test method development, statistical data analysis, and support of regulatory filings.
• Lead the continuous improvement of the quality system elements that support the design, development, and manufacturing transfer of new products.
• Maintain oversight of cGMP documentation, including, but not limited to product development reports, change control, validations, methods, and technology transfer.
• Ensure documents are thorough, accurate and compliant to support regulatory inspections and submissions.
• Provide support for investigations and recommend, develop and implement effective corrective actions.
• Provide support during regulatory inspections and customer audits.
• Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
• Proactively investigate, identify and implement improved quality practices.
• Ensure operations within approved department budget.
• Responsible for personnel actions including hiring, performance management, and termination.
• Ensure compliance in compiling and maintenance of Design History Files.
• Drive a consistent approach to Design Controls across all the business units in Convatec.
• Define and manage KPIs for related Quality Management Systems, in partnership with T&I.
• Ensure timely investigations and implementation of corrective actions related to design.
• Permanent quality member for stage gate reviews/approvals.
• Part of the T&I extended leadership team.
• Part of the GDC site leadership team, including quality oversight of test laboratories that execute design validation, verification, and stability studies.
• Management representative for GDC.
• Ensure that QMS requirements are effectively established, implemented, maintained, and documented in accordance with standards and regulations identified in the reference section of the quality manual.
• Report to management on the effectiveness of the quality management system and any needs for improvement.
• Ensure the promotion of awareness of the applicable regulatory and QMS requirements throughout the organization.
• Ensure quality policy is understood, implemented, and maintained at all levels of Convatec.
• Have oversight and support quality activities at the Convatec Canada Ltd site as well as the Boston development site, ensuring compliance on the execution of the processes.
• Lead 3rd party due diligence related to design quality/design controls.
• Lead, direct, or execute vendor approval audits related to new product introductions.
• Direct a team of design assurance and quality system managers with direct assignments to each business unit, ensuring close partnership with T&I on the development & launch of new products.
• This team covers design activities at all locations across Convatec, and includes software as a medical device.
• Has a total of minimum 7 direct reports, including global process owners for critical technical functions that impact all of Convatec (risk management and statistical techniques).

Your key contacts:

• Internally: Global quality management, T&I, M&A, Legal, Regulatory Affairs, Clinical Affairs, Quality Engineering, and all other functions as required by the role.
• Externally: Regulatory Authorities and Notified Bodies.

What we are looking for in you:

• Breadth of professional field and industry knowledge.
• Experience working in Quality Systems/Processes that cover Medical Device Design Controls and Pharmaceutical Development preferred.
• Ability to integrate critical information and champion advanced strategies/concepts through the organization.
• Drives development of advanced technologies, principles and processes.
• Ensures budgets, schedules, and performance requirements are met.
• Judgement is required in resolving complex problems based on experience.
• The ability to work in a cross functional team and ensure compliant project execution is a must.
• Deep understanding of Design Controls and Design Change Process.
• Experience working in an international environment in a global position is preferred.
• Minimum of B.S., or equivalent, in a scientific/technical discipline is required. Advanced degree (M.S., M.B.A, Ph.D. or equivalent) preferred.
• Certifications in Quality Management Systems preferred.
• Ten+ (10+) years in the medical device and/or pharmaceutical industry.
• Five to seven (5-7) years experience in a leadership role.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Written and spoken English. Another language would be an advantage.

Key competencies:

• Ability to think in clear, decisive manner, remaining calm under stressful and challenging conditions.
• Ability to efficiently work through quality, organization and business issues with a focus on solutions and proactive contingency planning in support of the customer and business objectives.
• Ability to apply budgetary analysis principles and effective allocation of internal/external resources.
• Understanding of risk management principles and ability to apply these principles in day to day quality management activities, compliance issues, and business challenges.
• Commercially astute and customer focused.

The role will require c25% travel.