About 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 more than 10,000 colleagues, we provide our products and services in around 90 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 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit
Position Overview:
1. To support B2B quality agreement/contracts from a documentation creation/maintenance perspective.
2. Supports global oversight of the Document, Change and Records Control Processes.
3. Facilitates compliance to FDA 21 CFR Part 820, ISO 13485:2016, and other applicable global Quality System Regulations.
4. Maintains the administrative tasks for global Document, Change and Records Control Processes.
5. Prepares, provides, and analyses metrics for Documentum and Change Control.
Key Responsibilities:
6. Applies Change Control, Documentation Control and Record Retention per 21 CFR Part 820, ISO ISO13485 and Medical Device Single Audit Program (MDSAP).
7. Provides guidance of Document, Change and Records Control Processes and Framework.
8. Works cross functionally across sites to bring harmonisation and to ensure compliance and effectiveness of the Global Documents, Change Control and Record Management.
9. Ensures that Global documents are routed, reviewed, approved, controlled, and implemented in accordance with established procedures.
10. Reviews Global documents for accuracy and completeness in formatting and content.
11. Ensures company records are retained and available for use in accordance with established procedures.
12. Support internal and external audit activities including FDA Inspections and ISO certification/surveillance audits.
13. Proactive and flexible to adapt to a swiftly changing environment in regulations, methodology and technology.
14. Establishes strong relationships with key stakeholders to foster compliance with Document Control and Change Control initiatives.
15. For TrackWise Change Control Module: Identify and assist with the implementation of updates to the Change Control TrackWise module; including participating in validation efforts, user acceptance testing.
16. For Documentum Document Control Module: Identify and assist with the implementation of updates to the Documentum Document Control Module; including participating in validation efforts, user acceptance testing.
17. Ensuure timely provision and reporting of metrics for Change Control and Document Control on a periodic basis.
18. Advocate for Continuous Improvement
Skills & Experience:
19. Intermediate skill level utilising electronic systems for management of the EQMS (D2 and Trackwise experience is desierable).
20. Knowledge of the application of requirements of ISO 13485:2016, 21 CFR Part 820, and the Medical Device Single Audit Program (MDSAP).
21. Ability to work in a fast-paced environment is crucial.
22. Capable of working to challenging timelines and able to priotise multiple tasks but with the flexibility to meet changing needs and priorities of the business.
23. Ability to communicate effectively in both oral and written communications, and work with employees at all levels of the organization.
24. Ability to work without close supervision and produce quality work.
25. Excellent computer skills: MS Office (Outlook, PowerPoint, Word, and Excel), and Adobe Acrobat Pro.
26. Ability to communicate with diverse teams (R&D, Engineering, etc.) and functions to foster efficient processes, continuous improvement, and integration across the organization.
27. Excellent analytical, evaluative and problem-solving abilities.
28. Desire to learn and a natural curiostity to understand systems and processes.
Qualifications/Education:
29. Bachelor’s Degree in Life Sciences or related discipline preferred.
30. Minimum 3 years supporting a global Quality Management System process in the medical device or healthcare industry.
Desirable:
31. Internal Auditor Qualifcation
Languages
32. Fluent in English (Mandatory)
33. Proficient in Spanish or Danish (Optional)
Working Conditions:
34. Remote Working
Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet.
This is stepping outside of your comfort zone.
This is work that’ll move you.
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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 .
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.