Sterility Assurance Associate

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 www.admedsol.com

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

We're looking for a dynamic and proactive STERILITY ASSURANCE ASSOCIATE to join our team. This role is crucial for acting as a Subject Matter Expert (SME), providing technical expertise, guidance, and support for all sterility assurance activities. You'll play a key part in ensuring the regulatory compliance of our sterilization methods, the development of our quality system, and the management of critical projects across our entire product portfolio. You will report directly to the Group Sterility Assurance Director.

What will this role involve?

Sterilization Expertise & Compliance:

• Act as a technical expert to support all sterility assurance activities, providing technical expertise and guidance to various teams and sites within the group.
• Ensure compliance with applicable national/international standards (e.g., ISO 11135, ISO 11137, ISO 17665) related to sterilization methods for the entire product portfolio and its expansions.
• Guarantee that sterility assurance complies with the requirements of cGMP, applicable MDSAP regulations, and the Medical Device Regulation (MDR) across the Group.

Sterilization Projects & Strategy:

• Participate in the representation of sterility assurance throughout all product design and development lifecycle phases to ensure product sterility, reliability, and cost-effectiveness.
• Contribute to determining the adequacy of sterilization methods in accordance with applicable regulations and standards.
• Assist in managing specific projects related to sterilization changes and be proactive in their implementation and development.
• Participate in regular communication meetings with cross-functional teams to identify the root cause of problems and create remedial plans for short-term and long-term resolutions.

Quality Management System (QMS):

• Review updated standards and provide information for effective gap analysis of validations/procedures at the site level.
• Ensure all related QMS processes are kept up to date with the latest versions of applicable standards and industry guidance.
• Transpose applicable national/international standards into quality system procedures and implement them across all sites.
• Create and review documentation associated with the quality system related to sterility assurance, including but not limited to: quality plans, verification/validation protocols, risk assessment documentation, and updates to quality system and department procedures.
• Support activities associated with aspects of the Quality Management System, including monitoring Non-Conformances, CAPAs, SCARs, Audit observations, participating in Material Review Boards (MRB), and attending change control meetings.

Support & Audits:

• Provide support to commercial and R&D teams on activities impacting validated sterilization methods, packaging, and cleanrooms.
• Assist in the assessment of non-conforming material related to sterilization.
• Act as a technical expert for Sterility Assurance during external audits (Notified Body, Competent Authority) and supplier audits.
• Participate in audits of sterilization subcontractors.
• Provide technical support for major sterility assurance investigations to help identify root causes and implement appropriate corrective actions.

What we're looking for?

• You hold a minimum of a Bachelor's degree (Bac+3) or equivalent in a scientific discipline (biology, microbiology, quality, pharmacy, engineering), or you have significant experience of at least 2 years in the medical device or pharmaceutical industries.
• You have proven experience with at least one major sterilization method (e.g., Gamma/EO) and the application of the applicable ISO standard, or microbiology experience within medical devices.
• You possess an in-depth knowledge of the Medical Device Regulation (MDR), cGMP/cGLP.
• Lead Auditor certification to ISO 13485 is preferred but not essential.
• You are proficient in Microsoft Office Suite (Word, PowerPoint, Excel).
• You are capable of independently planning, executing, and/or problem-solving moderate to complex situations.
• You demonstrate good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• You have the ability to manage multiple projects simultaneously and prioritize effectively.
• Your written and oral communication skills are excellent to ensure concise report generation and effective communication with staff and peer groups across the organization.