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Full Job Description
Job Description
Who are Advanced Medical Solutions?
AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices, and internal sealants, which it markets under its brands LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec, and Seal-G. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. AMS's products, manufactured across multiple countries, are sold globally via a network of partners and distributors, as well as through AMS's own sales forces in key regions. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel. Established in 1991, the Group employs over 1,500 staff. For more information, please see...
AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce, meaning that no one will be discriminated against because of gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.
Role Responsibilities
* Manage and monitor the Quality Systems to ensure compliance of the site.
* Act as a Subject Matter Expert for Quality Systems, providing guidance across teams.
* Implement, maintain, and train on Quality System processes.
* Manage document and record control processes, ensuring compliance with standards and good documentation practices.
* Oversee the Change Control process, supporting change owners and maintaining effective management.
* Facilitate regular meetings related to Quality processes such as Change Control.
* Manage the internal audit process, including scheduling and adherence monitoring.
* Support internal and external audits, tracking findings and resolutions.
* Monitor and measure the site’s training processes.
* Represent the site for Compliance Navigator, reviewing standards and facilitating gap assessments.
* Deliver GMP and GDP training to relevant personnel.
* Perform other duties as needed to support business operations.
Candidate Requirements
* BSc or equivalent in a scientific discipline, or at least 2 years’ experience in the medical device or pharmaceutical industries.
* Knowledge of applicable Quality System Regulations and ISO requirements.
* Experience with Change Control, Internal Audit, Document, and Record Control.
* Strong organizational skills and ability to manage time effectively.
* Proficiency in spreadsheets and word processing applications.
* Ability to independently plan, execute, and solve moderate to complex problems.
* Good judgment within defined practices and policies.
* Excellent communication skills, both oral and written.
* Ability to manage multiple projects simultaneously.
* Proven experience in delivering effective training.
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