Global Change Control and Documentum Coordinator (1-Year Contract)
Convatec — Paddington, England, United Kingdom
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 http://www.convatecgroup.com
Position Overview
* To support B2B quality agreements/contracts from a documentation creation/maintenance perspective.
* Supports global oversight of the Document, Change and Records Control Processes.
* Facilitates compliance to FDA 21 CFR Part 820, ISO 13485:2016, and other applicable global Quality System Regulations.
* Maintains the administrative tasks for global Document, Change and Records Control Processes.
* Prepares, provides, and analyses metrics for Documentum and Change Control.
Key Responsibilities
* Applies Change Control, Documentation Control and Record Retention per 21 CFR Part 820, ISO 13485 and Medical Device Single Audit Program (MDSAP).
* Provides guidance on Document, Change and Records Control Processes and Framework.
* Works cross-functionally across sites to harmonise and ensure compliance and effectiveness of Global Documents, Change Control and Record Management.
* Ensures Global documents are routed, reviewed, approved, controlled, and implemented in accordance with established procedures.
* Reviews Global documents for accuracy and completeness in formatting and content.
* Ensures company records are retained and available for use in accordance with established procedures.
* Supports internal and external audit activities including FDA inspections and ISO certification/surveillance audits.
* Adapts proactively to a swiftly changing regulatory, methodological and technology landscape.
* Establishes strong relationships with key stakeholders to foster compliance with Document Control and Change Control initiatives.
* For TrackWise Change Control Module: identify and assist with updates to the module, including participating in validation efforts such as user acceptance testing.
* For Documentum Document Control Module: identify and assist with updates to the module, including participating in validation efforts such as user acceptance testing.
* Ensure timely provision and reporting of metrics for Change Control and Document Control on a periodic basis.
* Advocate for Continuous Improvement.
Skills & Experience
* Intermediate skill level using electronic systems for management of the EQMS (D2 and TrackWise experience desirable).
* Knowledge of ISO 13485:2016, 21 CFR Part 820, and Medical Device Single Audit Program (MDSAP).
* Ability to work in a fast-paced environment with challenging timelines and multiple priorities.
* Effective written and oral communication; ability to work with employees at all levels.
* Ability to work with minimal supervision and produce quality work.
* Excellent computer skills: MS Office (Outlook, PowerPoint, Word, Excel) and Adobe Acrobat Pro.
* Ability to collaborate with diverse teams (R&D, Engineering, etc.) to foster efficient processes and continuous improvement.
* Strong analytical, evaluative and problem-solving abilities.
* Desire to learn and curiosity to understand systems and processes.
Qualifications/Education
* Bachelor’s Degree in Life Sciences or related discipline preferred.
* Minimum 3 years supporting a global Quality Management System process in the medical device or healthcare industry.
Desirable
* Internal Auditor Qualification
Languages
* Fluent in English (Mandatory)
* Proficient in Spanish or Danish (Optional)
Working Conditions
* Remote Working
Employment details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Other
* Industries: Medical Equipment Manufacturing
Important notices
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, disability, sexual orientation, gender identity, military or veteran status, 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 as a result of an unsolicited agency or search firm referral.
If you are an active Convatec employee, please use the internal career site to apply.
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