Senior Manager, Quality Management Systems (QMS)

at  ConvaTec

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 atrisk 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.
Our search for better is changing the lives of our customers. It’s changing the careers of our people too –creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as Senior Manager, Quality Management Systems, and you won’t either.

JOB SUMMARY:

This is a key role within the Global Quality function, where you will lead the Quality Management Systems (QMS) team as well as manage Quality Management System (QMS) processes, to include: Document Control, Change Control, and Corrective and Preventative Actions (CAPA).
The Senior Manager, Quality Management Systems (QMS) will lead a team responsible for timely deliveries according to our quality and compliance plans. We are looking for a QMS Lead who can develop the Team and bring focus to deliverables and KPI’s.

TRAVEL REQUIREMENTS

Travel is expected 10-20 days per year.

EDUCATION/QUALIFICATIONS

• Degree or equivalent in Science or Engineering
• Minimum of 5 years quality management system handling experience (required)
• Experience with NC/CAPA system and review (preferred)
• Experience with CCR system and review (preferred)
• MS Office, TrackWise experience (required)
• Training in EU MDR, ISO 13485 and MDSAP (required)
• Audit experience (preferred)
• Project management experience / Industry memberships / Professional Registrations (preferred)

LANGUAGE SKILLS REQUIRED:

Speaking: Yes English
Writing/Reading: Yes English

ABOUT US

We offer you a position in a dynamic and global company with great benefits and flexibilities for the employees and where the days are never the same. Convatec will provide you with challenges and development opportunities and the chance to influence your own role. You will be a part of a great community where we all help and support each other – while continuously building on our competences and network. Interviews will be conducted continuously, so we encourage you to submit your application (in English) as soon possible. In case of questions to the position.
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

Key Duties & Responsibilities

• Lead the QMS Team
• Host Notified Body audits and plan the audit management
• Bring structure and motivation and facilitate cross-functional teamwork
• Ensure efficient and operational systems and procedures and alignment with our manufacturing sites in Reynosa (Mexico)
• Ensure Quality awareness around the organization with focus on NC/CAPA and Change Control
• Establish and maintain a productive relation with the relevant stakeholders based on trust and respect.
• Reporting Team and KPI status on monthly basis (or as needed) to Leadership Teams
• Supporting the global quality team with creation, consolidation, and simplification of strategies and company Quality programs/projects