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. Group revenues in 2024 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 a CAPA Manager, Global Quality Management Systems, and you’ll do the same.

About the role:

As a CAPA Manager, you will lead and oversee the global NC/CAPA process, ensuring continuous improvement and compliance with medical device standards and regulations. You will manage daily operations, facilitate development of efficient processes, and deliver quantifiable savings. Your role involves collaborating with internal teams and external partners, supporting audits, and acting as a subject matter expert.

Your key duties and responsibilities:

• Demonstrate methodical problem-solving skills in a fast-paced continuous improvement culture.
• Use and promote the benefits of structured and standardized Lean / Six Sigma /KT methodology for process improvement and development.
• Work with internal team members, including across functions, and external partners around the globe and is expected to operate professionally in all elements of interaction including but not limited to all phases of project management.
• Identify and leverage best practices throughout the organization.
• Facilitate the development of efficient, effective, and fully compliant processes that meet the requirements of all global regulations and deliver quantifiable savings from process efficiency.
• Support internal and external audits.
• Owns and oversees the global NC/CAPA process including monitoring process performance and implementing continuous process improvement.
• Oversees daily operational aspects of the NC/CAPA Process.
• Collaborates with the Quality Manager Improvement to review and finalize monthly and quarterly NC/CAPA metrics. Run ad hoc reports as necessary.
• Leads global and site NC/CAPA continuous improvement workshops.
• Develops and provides general training to the global and site NC/CAPA team and other applicable users as necessary. Will also facilitate training when changes are made to the process, procedure, or TrackWise (TW) system.
• Participates as a NC/CAPA subject matter expert during internal and external audits.
• Lead process performance review meetings with the global NC/CAPA team.
• Lead Corporate and local site CAPA Review Board meetings.
• For TrackWise Event/CAPA Module: Identify and assist with the implementation of updates to the NC/CAPA TrackWise module; including participating in validation efforts e.g. user acceptance testing.
• Assists in the preparation and execution of site Management Review meetings.
• Participates as a site internal auditor if competency requirements are satisfied.
• Maintains strong knowledge of medical device standards / regulations.
• Acts as delegate of Associate Director Global Quality Management System.

Skills & Experience:

• Comprehensive understanding in mechanism and key components in Quality Management System.
• Knowledge of regulations and standards in the quality management system for Medical Devices, e.g. ISO 13485, MDSAP.
• Willingness to adhere to all principles of confidentiality.
• Comfortable working in a highly regulated, fast-paced environment.
• Effective and proactive communication, particularly in a remote-working situation.

Qualifications/Education:

• Bachelor’s Degree in Science, Engineering, or related discipline.
• Minimum 5 years supporting a global Non-Conformance/CAPA process in the medical device or healthcare industry.
• Intermediate to Expert skill level utilizing TrackWise.
• Knowledge of and the ability to translate and apply the requirements of ISO 13485:2016, 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP).
• Ability to deal with difficult situations with tact and professionalism.
• Ability to communicate effectively in both oral and written communications, and work with employees at all levels of the organization.
• Demonstrate problem solving and trouble shooting skills.
• Ability to work without close supervision and produce quality work.
• Proficient computer skills: MS Office (Outlook, PowerPoint, Word, and Excel), Microsoft Teams, and Adobe Acrobat Pro.

Working Conditions:

• This role may be based in the United Kingdom with a remote working structure - office presence will be required or allowed for certain meetings, events, or to meet certain business needs.

Travel Requirements:

• Position may involve travel up to 10% of the time, this may include overseas travel. Most trips will include overnight travel.

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.

This is stepping up to a challenge.

This is work that’ll move you.

#LI-CC1

#LI-Remote

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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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