Job Details
About AMS
Who are Advanced Medical Solutions?
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
Job Details
The purpose of this role is to support the Group Quality Process Team in delivering the Quality Assurance Strategy, aligning with corporate goals and objectives. The role involves ensuring compliance with regulatory requirements through the effective implementation and continuous improvement of the Quality Management System (QMS), with a specific focus on software validation.
Key responsibilities
What this role involves:
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.
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
Job Details
The purpose of this role is to support the Group Quality Process Team in delivering the Quality Assurance Strategy, aligning with corporate goals and objectives. The role involves ensuring compliance with regulatory requirements through the effective implementation and continuous improvement of the Quality Management System (QMS), with a specific focus on software validation.
Key responsibilities
What this role involves:
- Lead validation activities for new software systems, ensuring alignment with regulatory requirements.
- Collaboration with cross-functional teams to support the implementation of new systems while ensuring compliance with quality standards.
- Oversee continuous improvement of quality processes, with a specific focus on validation and software-related procedures.
- Manage Corrective and Preventive Action (CAPA) processes related to validation and software quality issues.
- Drive document management processes, particularly those related to software validation documentation.
- Ensure accuracy, accessibility, and compliance with regulatory standards for all relevant documents.
- Contribute to the development and execution of project management activities, with a particular focus on software projects.
- Collaborate with audit stakeholders to identify areas for improvement and facilitate corrective actions.
- Ensure quality systems across the AMS Group, with an emphasis on software-related processes, comply with applicable GAMP, cGMP, MDSAP, and Medical Device Regulation (MDR).
- Lead the development and improvement of the quality management system across the AMS Group with a focus on software validation.
- Note: This a remote position, 15% travel to sites will be expected when required.
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.
- BS or equivalent in scientific discipline or comparable experience in the medical device or pharmaceutical industries.
- At least 2 years of experience in medical device or pharmaceutical industries.
- Proficiency in applicable Quality System Regulations, ISO quality requirements, and specific regulations like GAMP, 21 CFR Part 11, and Eudralex.
- Ability to develop and implement quality improvement initiatives, including tracking, analysing, and reporting on progress and effectiveness.
- Strong written and oral communication and presentation skills for effective communication with staff, peer groups, etc., across the organisation.
- Proficiency in Word, Excel, and PowerPoint for documentation and presentation.
- Effective time management, task prioritisation, and the ability to meet critical deadlines while supporting multiple projects.
