Senior Quality Assurance Specialist in Elstree at Stryker Corporation

Date Posted: 10/8/2018

Job Snapshot

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Job Description

Your key responsibilities

  • Responsible for aspects of quality assurance activities, including;
    • Administration of SIW’s internal audit programme.
    • Administration of SIW’s Quality Management System maintenance through document control.  
    • Document control lead for external audits.
  • Construct/maintain documents to include SOPs, internal audit files and other controlled documents.
  • Ensure Quality Management System compliance.
  • Support QA staff working in response to requests from regulatory agencies, collating and interpreting specialised information.
  • Perform other duties as assigned.

What are we looking for?

  • Degree qualified or equivalent.
  • Worked in medical device industry for minimum of 3 years.
  • Worked in a regulated environment in line with ISO 13485 and US FDA 21 CFR 820.
  • Knowledge of medical device relevant legislation and guidance documents pertaining to RA/QA activities in Europe and USA.
  • Certified Quality management systems auditor
  • Working knowledge of requirements for Quality Management System requirements in Europe and USA.
  • Proactive and self-motivated.
  • Strong ability to multi-task.

Work From Home: No

Travel Percentage: None

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