Quality System Analyst

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 in various countries, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces. 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.

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.

Responsible for the effective management of the Quality Systems to aid in maintained compliance of the site. This will be applied through the actioning, management and monitoring of key Quality Processes including reporting on the effectiveness of the Quality Management System.

Acting as Quality Systems Subject Matter Expert to provide guidance for the application of Quality Systems practices and techniques to the wider Quality team and cross-functional departments.

What the role involves:

• Owner of the Quality Systems processes, responsible for implementation, maintaining, management, training and monitoring of such.
• Responsible for the management of document and record control processes including maintaining compliance with applicable standards and Good Documentation Practices and Management of the Document Update process.
• Owner of the Change Control process, providing support and guidance to Change Owners, maintaining effective Change Management.
• Organises and facilitates regular meetings for applicable processes such as Change Control.
• Management of the internal audit process including setting the audit schedule and monitoring and facilitating adherence to the schedule.
• Quality support for internal and external audit findings, including the monitoring and measuring of completion and timeliness.
• Monitoring and measures of the Training process for the site.
• Site representative for Compliance Navigator, reviewing and facilitating gap assessments for new/updated standards.
• Delivering of GMP and GDP training to all applicable personnel.
• Perform any other related duties as/when business needs arise.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

What we're looking for:

• BS or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 2 years’ experience in medical device or pharmaceutical industries.
• Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements.
• Must have knowledge of Change Control, Internal Audit, Document and Record Control.
• Excellent organisational skills and a demonstrated ability to effectively manage own time.
• Proficient in spreadsheets and word processor applications.
• Ability to independently plan, execute, and/or problem solve moderate to complex situations.
• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Solid oral and written communication skills.
• Ability to manage multiple projects.
• Proven experience in delivering training effectively.