Quality Assurance Engineer

Zoek Pin Wrexham, Wales

Market related

Permanent (Full time)

Posted 43 days ago

Our client is currently looking for a Quality Assurance Engineer to join their busy team!

Hours of Work: Days 8:30am - 4:30pm (Plus Flexitime) Mon - Fri

Quality Assurance Engineer Duties:

Document Control

  • Checking updated procedures comply with requirements of ISO 9000 (2015).
    This includes updating procedures and specifications requested by internal departments to capture changes working practices. Management of approval signatures, issuing, cancellation and archiving of old documents (both electronic and hard copies).
  • Generating updates to the Quality Manual as detailed by the Quality Manager.
  • Acting as signatory or back up signatory for Quality Manager
  • Keeping Quality System Database updated

Auditing

  • Assist Quality Manager in planning of internal audit schedule.
  • Manage company internal audit program compliant with ISO 9000(2015) requirements.
  • Participating in customer audits.

Corrective Actions

  • Initiating and follow up of internal corrective actions.
  • Review monthly overdue corrective/follow up actions with Quality Manager

Job Filing and Certification

  • This includes:

  • Checking QC and production documentation generated for each run and generating a job file. Keep job file database up to date.

  • Archiving job files and send for digital storage. Meet medical customer retention requirements.

  • Generating Certificates of Conformance and Certificates of Analysis as required by various Customers.

Other

  • Attending the Management Review meeting and taking minutes from the meeting to assist the Quality Manager with the report for the Review meeting.
  • Understanding the requirements of our medical customers and ISO 13485 system requirements

Quality Assurance Engineer Requirements:

  • Excellent communication skills
  • Managing interfaces
  • Planning & organising
  • Monitoring & evaluating
  • Computer literate to high level
  • Presentation skills
  • Clarity of thought
  • Acting in a consistent and appropriate manner
  • Being proactive

Knowledge of the following:

  • ISO 9001
  • ISO 13485
  • Company procedures and systems
  • Customers / competitors
  • Knowledge of the work system
  • Computer systems and capabilities
  • Statistical knowledge / background
  • Operation of QMS
  • Clean Room Manufacturing

If you think that you are suitable for this Quality Assurance Engineer role, please apply now!

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