Quality Validation Specialist

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 Liqui Band®, RESORBA®, Liqui Band Fix8 ®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®.

AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its Activ Heal® brand as well as under white label. Since 2019, the Group has made seven acquisitions:
Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices.

AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel.

Established in 1991, the Group has more than 1,500 employees. For more information, please see

• Performing Quality Engineering tasks and owning the site level Validation process, ensuring timely completion of Validations and providing support to specific validation owners.
• To support the achievement of measurable continual improvement and quality & regulatory compliance across the business.
• Working with Manufacturing, Supply Chain, Quality Departments & R&D, plus supporting other functions, to;
• Evaluate and improve effectiveness of processes and procedures and efficiency of working to improve cost performance and product yields.
• Maintain and improve quality compliance.
• Identify, manage and implement continuous improvement initiatives.
• Evaluate product and process risks through the application of Medical Device Risk Management requirements.
• Support New Product Introductions.
• Support and progress changes requests.
• Ensure that employees are aware of and have working knowledge of quality and regulatory medical device requirements through the development and delivery of training programmes.
• Management of the on-site validation processes and acting as quality approver of such.

What will this role involve?

• Develop, generate, maintain and/or documentation to support an effective and compliant Quality Management System, including:
• Product and Process FMEAs / Risk Assessments.
• Medical Device Risk Management Reports and Files.
• Validation schedules, plans and reports.
• Quality Inspection Procedures and Control Plans.
• Sampling Plans.
• Material and Product Specifications.
• Process Flow Charts.
• Quality Systems and Process SOPs and Work Instructions.
• Ownership of the validation process, providing support and guidance to cross-functional teams performing validations. Writing Validation documentation where required.
• Rapid investigation and resolution of customer reported quality issues.
• Initiate, track, report and trend non-conformities.
• Root cause analysis and problem solving for identified nonconformities and facilitate implementation of actions to increase efficiency and further enhance product…