Collins McNicholas

The position requires an experienced and proven candidate with a background in Quality and Regulatory control of Medical Devices. The successful candidate will work as part of a team to maintain high quality/performance standards across the company.

Reporting to the Senior Quality / Regulatory Manager, the position will be challenging and will require an ability to work autonomously

Roles & Responsibilities

The Senior Quality Engineer shall:

  • Act as the QA representative on Design Services Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation.
  • Develop and maintain documentation in compliance with FDA, ISO, MDD requirements
  • Initiate / Approve Validation protocols and reports (IQ, OQ, PQ)
  • Initiate / Approve Engineering Change notices
  • Process Customer Complaints and manage customer replies
  • Actively participate in the Documentation control process
  • Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations
  • Participate / Lead Risk Analysis initiatives e.g. FMEA
  • Initiate / Approve Reworks
  • Initiate / Support implementation of effective Corrective / Preventive Actions
  • Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.
  • Represent QA as part of the Material Review Board
  • Perform Internal and Supplier Audits
  • Support Notified Body / Regulatory Agency / Customer Audits
  • Review / Approve / Release final product documentation
  • Support the Environmental monitoring process
  • Support activities associated with Sterilization
  • Act as the QA representative for Supplier Quality management activities
  • Collate and trend Key performance indicator data
  • Actively participate in Management Review & Compliance meetings
  • Act as delegate for Quality Manager when required
  • Performs other related duties, as assigned

 

 Role Requirements

A degree in manufacturing engineering, quality engineering, life science or related field and a minimum of 5 yrs. experience within the Medical Device Industry.

Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.

Experience of using Lean Manufacturing Tools and Techniques an advantage

Quality Certification and Lead Auditor Certification while not mandatory would be an advantage.

 

For a confidential discussion and a more detailed job description (or more information on the role), please contact Christopher O Toole on 091706713 

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