QMS Lead Specialist - 1 Year Contract - 27074BR - EN in Newbury at Stryker Corporation

Date Posted: 3/10/2018

Job Snapshot

  • Employee Type:
  • Location:
  • Job Type:
    Quality Assurance
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

Key Activities & Accountabilities:
We are seeking a QMS (Quality Management System) Specialist for a 1 year contract to be based in the Stryker UK distribution site located in Newbury, Berkshire. This position will be responsible for the maintenance and improvement of the Stryker UK quality management system according to ISO 9001:2015 and internal Stryker Corporate/Europe requirements.

(Note: In addition to these activities employees are required to carry out such other duties as may reasonably be required)
  • Responsible for ensuring compliance with the ISO 9001 standard.
  • Develop and maintain the QMS and documentation system to ensure the site operates within approved Corporate and European process and procedures.
  • Utilise document control software (Workbench) to ensure that the document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS.
  • Ensure quality records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records.
  • Organize and lead annual Management Reviews of the Quality System to ensure and monitor its suitability, adequacy and effectiveness.
  • Implement a program of Internal Quality Audits covering all processes
  • Co-ordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed. Work with process owners to ensure timely CAPA investigation and closure.
  • Define and implement a QMS training program. Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary.
  • Analyse data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources
  • Support departmental process owners to identify, implement and document improvement opportunities.
  • Assist in creation of quality objectives for RAQA and non-RAQA departments
  • Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with internal and external requirements/standards.
  • Report to top management on the performance of the QMS and any need for improvement.
  • Partner with other QMS/QA Specialists across Europe to establish best practice and standardise processes where possible.
  • Liaise with the external assessment body on all matters related to the external accreditation process.
  • When requested, provide support to other members of the UK Regulatory team to facilitate the meeting of their requirements / targets.
  • Ensure distributors are regularly audited in line with Stryker requirements.
  • Ensure that all suppliers used by the organisation are selected, evaluated and re-evaluated and that records of this assessment are maintained.

Position in structure
  • Standalone QMS role for region
  • Member of the UK RAQA Team reporting directly to the UK RAQA Manager

Equipment / software packages used:
  • Microsoft Outlook, Excel, Word, PowerPoint, Visio.
  • Adobe Acrobat and Reader
  • Oracle ERP System
  • Workbench Professional
  • Trackwise – used for complaint handling and monitoring of regulatory actions
  • SharePoint
  • Skype
  • ComplianceWire – online learning management system

Working conditions / degree of effort required:
  • Office based ~ 98%
  • Travel required ~ 2% (Stryker Europe Distribution site visits / distributor audits / team meetings)

Job Requirements

Qualifications / education required:
  • Degree educated or equivalent
  • Scientific, Engineering or law background preferable (but not essential).

Experience required:
  • Minimum 3 years experience in Quality Management within an international medical device company
  • Knowledge of Quality Management environment
  • ISO 9001/13485 Qualified Lead Auditor
  • Experience of hosting external certification audits
  • Knowledge of the Medical Devices Directive and associated local laws.

Any other particular aptitude / skill required:
  • Ability to build relationships with colleagues across multiple countries and cultures.
  • Excellent communication skills with proficiency in spoken and written English.
  • Combination of analytical and abstract way of thinking.
  • Problem solver.
  • Resourceful self-starter who doesn‘t require close supervision to meet tight deadlines
  • Able to handle multiple and diversified tasks.
  • High level influencing strengths.
  • High ethical standards and integrity.
  • Ability to positively contribute in supporting and developing a pan European Professional Team

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