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Quality Engineer

2 months ago

Winsford, United Kingdom Advanced Medical Solutions Full time
Job Description

Group Quality CSV Engineer, Winsford.



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, 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


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 their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law.


Job Details


To ensure compliance with regulatory requirements and internal standards for Computer System Validation (CSV) activities across the business. The role involves supporting the validation and revalidation of software systems and applications, ensuring these systems are compliant with applicable regulations such as GAMP, 21 CFR Part 11, and ISO 13485. This includes managing change control processes, patch updates, risk assessments, and periodic reviews to maintain validation and operational integrity.


The Group Quality CSV Engineer will provide expertise and oversight for the validation lifecycle of computerised systems, ensuring robust documentation and adherence to best practices across all AMS sites.


What will this role involve?

  • Support the validation and revalidation of software systems and applications to ensure compliance with regulatory standards and internal policies.
  • Develop and maintain validation documentation, including validation plans, protocols, and reports, for all computerised systems.
  • Conduct and document risk assessments for software systems to identify and mitigate potential compliance issues.
  • Monitor and manage change control processes related to software systems, ensuring changes are validated and documented appropriately.
  • Collaborate with IT and operational teams to implement and review patch updates, upgrades, and system changes while maintaining compliance.
  • Plan and execute periodic reviews of computerised systems to ensure continued validation and adherence to regulatory requirements.
  • Support the development and implementation of standardised procedures, templates, and policies for CSV processes across the AMS Group.
  • Provide guidance and training to teams on CSV requirements, ensuring alignment and understanding across all stakeholders.
  • Conduct audits and assessments of software validation processes and documentation to identify gaps and opportunities for improvement.
  • Support the successful execution of quality strategies, including harmonisation of computerised systems and related validation processes.
  • Ensure effective communication and coordination with AMS sites to implement consistent validation practices and regulatory compliance.
  • Perform other duties related to CSV and Quality Management as assigned.



What we're looking for?

  • A bachelor’s degree or equivalent in a scientific discipline, with a minimum of 2 years of experience in the medical device or pharmaceutical industries.
  • Proficiency in applicable Quality System Regulations and ISO quality requirements (Medical Device experience preferred).
  • Strong understanding of Computer System Validation (CSV) requirements and processes.
  • Experience with software validation standards, including GAMP and 21 CFR Part 11.
  • Demonstrated ability to maintain compliance in software systems through effective validation and lifecycle management.
  • Familiarity with quality improvement initiatives and tools to track, analyse, and report progress.
  • Ability to manage multiple projects, prioritise tasks, and meet deadlines effectively.
  • Experience working in multidisciplinary teams and supporting cross-functional collaboration.
  • Proficiency with Microsoft Office tools, including Word, PowerPoint, and Excel.
  • Strong written and oral communication skills to document and present validation processes and outcomes effectively.
  • Analytical and detail-oriented approach to risk assessments and validation activities.
  • Familiarity with tools for data analysis and documentation in software validation contexts.