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. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
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.
In this role, you will be responsible for leading the Quality Design Assurance Team supporting new product development for ConvaTec. You will be the primary quality contact for the Technology and Innovation (T&I) group to support product launches and ongoing design changes.

Your Key Responsibilities:

• Lead, mentor, coach, and develop 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.
• Provides support during regulatory inspections and customer audits.
• Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
• Proactively investigates, identifies and implements improved quality practices.
• Ensure operations within approved department budget.
• Responsible for personnel actions including hiring, performance management, and termination.
• Ensures compliance in compiling and maintenance of Design History Files.
• Drives 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
• Ensures 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.
• Ensures 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.
• Reporting to management on the effectiveness of the quality management system and any needs for improvement.
• Ensuring the promotion of awareness of the applicable regulatory and QMS requirements throughout the organization.
• Ensuring 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).

• Lead, mentor, coach, and develop 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.
• Provides support during regulatory inspections and customer audits.
• Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
• Proactively investigates, identifies and implements improved quality practices.
• Ensure operations within approved department budget.
• Responsible for personnel actions including hiring, performance management, and termination.
• Ensures compliance in compiling and maintenance of Design History Files.
• Drives 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
• Ensures 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.
• Ensures 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.
• Reporting to management on the effectiveness of the quality management system and any needs for improvement.
• Ensuring the promotion of awareness of the applicable regulatory and QMS requirements throughout the organization.
• Ensuring 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)