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Quality Engineer in Belfast at Stryker Corporation

Date Posted: 3/13/2019

Job Snapshot

  • Employee Type:
  • Location:
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
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Job Description

Responsible for executing within a quality engineering team in integration, and supporting activities for MDSAP, ISO 13485: 2016 and MDR in addition to internal audit scheduling, execution and reporting for a class III medical device

The Quality Engineer will be responsible for the following activities:

Support the implementation, adherence and schedule relating to the Stryker corporate SOP for internal auditing  Ensure implementation and compliance with Stryker SOPs Support updates to labelling, SOPs, work instructions, trending tools and policy documents to comply with MDSAP, ISO 13485: 2016 and MDR Support external audit preparation and execution as required Support coordination of MRM, CRB, ARB, PRB as required Support CAPA/NC execution as needed

  • Qualifications:

2:1 in Engineering or Science or an equivalent qualification in QA or RA

  • Experience:

Minimum of 2 years’ experience in a regulated medical device or pharma business 

  • Specific Knowledge

An understanding of ISO 13485: 2016

An understanding of MDSAP regulations would be advantageous

Knowledge of 21 CFR part 820

Knowledge of ISO 14971 and ISO 14155 would be advantageous

Previous internal auditing experience and lead auditor training would be advantageous

  • System/Computer Requirements:

Basic Microsoft Office, MS Project, Adobe Acrobat

  • Key Competencies needed for this position?

      General knowledge of the relevant regulations

      Effective Communication Skills

      Highly developed technical writing skills

      Highly developed decision-making skills

Work From Home: No

Travel Percentage: Up to 25%

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