Quality Sytems Group Leader

Job content

About AMS
Who are Advanced Medical Solutions?

When we say we’re a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, we’re not joking. But we’re much more than that...

With over 700 employees across the globe, we pride ourselves on being able to create an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the correct environment to foster innovation, growth and meaningful work.

We’re highly dependent on the creativity of our employees for our future growth and success. Our motto ’Care, Fair, Dare’ summarises our culture, and defines the principles of how we operate as one team to achieve success.

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*
Responsible for the Quality Systems function to deliver and ensure compliance with international regulations and company procedures. Supports the development, maintenance and improvement of the Quality Management System. Provides guidance for the application of the MDSAP regulations and the Medical Device Regulation (MDR).
Supports management and guidance of external and internal audits of the QMS including interfacing with sites and regional competent authorities during all the steps of identifying, reporting and finalising any audit non-conformance.

Key responsibilities
What will this role involve?

• Day to day management of the Quality Systems team, providing coaching and ensures site requirements are met from the function
• Interprets and applies MDSAP/ MDR/ QMS regulations to ensure compliance with these regulations and any other new/revised applicable regulation
• Acts as support for interpretation and application of external standards, guidelines and initiatives to AMS Employees
• Serves as a subject matter expert QA Interface to other departments, customers and Regulatory Bodies
• Responsible for efficient and compliant change management process.
• Supports in the development and continuous improvement of the QMS
• Responsible for coordinating activities associated with aspects of the Quality Management System including:

*

• Policy, SOP / WI development and revision, as appropriate
• Review and assess document changes affecting procedures in accordance with internal procedures of a difficult and complex nature
• Support the approval, issuing and control of QMS documentation as required
• Supports Management Review meetings, establish data for presentation
• Responsible for raising and assessing customer complaints in Eqms system
• Provide monthly data for the following quality management system KPI’s
• Status of Change Management records
• Status of Site Procedure Training
• Status of audit records

• Facilitation of the change control review board, ensuring all actions meet compliance needs
• Support Supplier Quality Management activities such as supplier initiated changes, approved supplier lists, as required
• Supports the control and management of QMS changes in accordance with site change management procedures
• Supports the external and Internal audit schedules including:
• Performs Internal / Supplier / Group audits, as required
• Follow up on Audit Action progression
• Create monthly reports to management on the status of internal and external audits, open actions, overdue activities and future audits
• Support regulatory responses until closure, as required.
• Develops, analyses, trends, maintains and reports Quality metrics
• Participate in quality compliance teams and continual improvement where required
• Perform other related duties as assigned

What we’re looking for?
QUALIFICATIONTo 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.

EDUCATION AND EXPERIENCE
4 or more years’ experience in a compliance role within medical device or pharmaceutical industries/ regulated industry.

Skills/Knowledge

• Must have experience of performing Internal /external audits. ISO Certified Lead Auditors preferable.

• Must have knowledge of applicable regulations and standards related to medical devices internationally (ISO 13485, Medical Device Regulation, Anvisa, CFDA, etc.)
• Strong working knowledge of Microsoft Applications including Excel
• Ability to effectively train other individuals to Quality System procedures and programs
• Executes the planning, execution, and/or problem solving of simple to moderate situations.
• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

• Must be able to work collaboratively and have persistence with a determination to succeed
• Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel
• Ability to support QMS deliverables

Employment Basis
Full Time

Location Country
United Kingdom

Location City
Winsford

Applications Close Date
31 Dec 2021

Job Type: Full-time

Work remotely:

• No