Group Sterility Assurance Associate- Maternity Cover - Winsford, United Kingdom - Advanced Medical Solutions

Advanced Medical Solutions
Advanced Medical Solutions
Verified Company
Winsford, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

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

Job Details

  • Support across AMS Group to make sure Sterility Assurance is in compliance with the applicable requirements of cGMP, MDSAP applicable regulations and the Medical Device directive (MDR). Ensuring the development and improvement of the quality management system across AMS Group.
    Key responsibilities

What will this role involve?

  • Responsible for the representation of Sterility Assurance through all product design and development life cycle phases to ensure product sterility, reliability and cost effectiveness
  • To determine whether sterilisation methods are deemed adequate in accordance with applicable regulations and standards (eg ISO 11135, ISO 11137 & ISO for AMS product portfolio and expansions to product portfolio
  • Performs reviews of updated standards and provides information for effective gap analysis of validations/procedures at site level.
  • Ensures all related QMS processes are kept up to date with latest versions of applicable standards and industry guidance. Transposition of applicable national/international standards into quality system procedures and implement them across AMS sites
  • Create and review documentation associated with the AMS 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
  • Supports activities associated with aspects of the Quality Management System including
  • Status of Non-Conformances, CAPAs, SCARs, Audit observations
  • Participation in Material Review Board (MRB), where required
  • Participation in compliance meetings ( Change Control)
  • Customer complaints
  • Internal audits
Competent Authority) and supplier audits

  • Attend regular communication meetings with crossfunctional teams to identify the root cause of
problems and create remedial plans for short-term and long-term resolutions

  • Supports continual improvement projects in accordance with company objectives related to
sterilisation requirements

  • Any other duty as assigned, where required

What we're looking for?
Knowledge & Skills

  • 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.
  • Knowledge of the Medical Device regulation
  • Knowledge of cGMP/cGLP
  • Lead Auditor trained to ISO 13485 is preferred but not essential
  • Proficient in Microsoft Office (Word, PowerPoint, Excel)
  • 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
  • Ability to manage multiple projects
  • Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation

Employment Basis

  • Temporary
  • Maternity cover

Location Country

  • United Kingdom

Location City

  • Winsford

Applications Close Date

  • 30 Jun 2023
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