Quality System Analyst

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 offers a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices, and internal sealants, marketed under brands such as LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec, and Seal-G. The company also supplies wound care dressings like silver alginates, alginates, and foams through its ActivHeal brand, as well as under white label. Since 2019, AMS has made seven acquisitions, including Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. AMS's products are manufactured across several countries and sold globally via regional partners and its own sales teams. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and employs over 1,500 people worldwide. For more information, visit www.admedsol.com.

AMS is committed to providing equal employment opportunities and values diversity, ensuring no discrimination based on gender, race, age, nationality, disability, or other protected characteristics.

Role Overview

The successful candidate will be responsible for the effective management of the Quality Systems to ensure compliance at the site. This includes actioning, managing, and monitoring key Quality Processes and reporting on the effectiveness of the Quality Management System. The role involves acting as a Quality Systems Subject Matter Expert, providing guidance across departments.

What the role involves:

1. Owning the Quality Systems processes, including implementation, maintenance, management, training, and monitoring.
2. Managing document and record control processes, ensuring compliance with standards and Good Documentation Practices.
3. Overseeing the Change Control process, providing support and guidance to Change Owners.
4. Organizing and facilitating meetings related to Quality Processes such as Change Control.
5. Managing the internal audit process, including scheduling and adherence monitoring.
6. Supporting internal and external audit findings, ensuring timely resolution.
7. Monitoring and measuring the Training process at the site.
8. Representing the site for Compliance Navigator, reviewing and facilitating gap assessments for new standards.
9. Delivering GMP and GDP training to relevant personnel.
10. Performing other duties as required by business needs.

Candidate Requirements:

• BSc or equivalent in a scientific discipline or comparable experience, typically 2+ years in the medical device or pharmaceutical industries.
• Proficiency in applicable Quality System Regulations and ISO quality standards.
• Knowledge of Change Control, Internal Audit, and Document and Record Control processes.
• Strong organizational skills and effective time management.
• Proficiency in spreadsheets and word processing applications.
• Ability to independently plan, execute, and solve moderate to complex problems.
• Judgment skills within defined practices and policies.
• Excellent oral and written communication skills.
• Ability to manage multiple projects simultaneously.
• Experience in delivering effective training.