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QA/RA Manager - Expired

Job Title QA/RA Manager
Job Type Permanent
Industry
Salary €0.00 per annum + Competitive Salary
Location Clare, Republic of Ireland
Start Date ASAP
Our Reference BBBH582_1499703509
Job Advertised 4 months ago

This role requires a manager with a strong technical qualification and wide-ranging experience of medical device global quality and regulatory issues, particularly the US FDA and EU MDD requirements.

Responsibilities

  • Ensure compliance with the following medical device & software quality requirements;
  • EU Medical Device Directive
  • ISO13485 Medical Device QMS
  • FDA QSR 21 CFR 820
  • Japanese JPAL requirements
  • Health Canada SOR 98/282
  • Chinese CFDA requirements
  • FDA 21 CFR 11 guidance
  • ICH E6 GCP
  • Manage a QA/QC department of eight personnel
  • Manage Supplier/Vendor quality through a comprehensive vendor management program.
  • Perform reviews and audits as required.
  • Host regulatory body and customer onsite and remote audits
  • Prepare Regulatory filings;
  • CE device approvals
  • FDA 510(k) submissions
  • Japanese JPAL submissions
  • Health Canada submissions
  • Competent Authority registrations
  • Maintain the product and establishment registrations
  • Supervise the document control function including approval of all change control requests (engineering change notices, deviations and rework instructions)
  • Ensure upkeep of archives
  • Control and manage the eQMS system
  • Maintain regulatory oversight, plan and implement change programs to ensure continued compliance.
  • Identify and maintain key essential quality KPIs including regular reporting of quality metrics and issues
  • As Management Representative, co-ordinate management reviews and quality reporting to senior management
  • Manage the Complaints program. Perform reportability reviews and interact with all stakeholders.
  • Manage Issues and CAPA. Co-ordinate RCA and action plans with task owners.
  • Be the site quality representative on design teams including risk management approvals, NPI and design transfer.
  • Co-ordinate an Internal Audit program covering QMS and process audits.
  • Participate in and give training on quality and regulatory matters including the eQMS.
  • Prepare and submit annual plans with focussed targets and associated budget.
  • Manage product quality through co-ordination of goods receiving QC, in process QC and final inspection release activities.
  • Travel to other sites to work as part of duties will be required

Qualifications and Experience

  • Minimum BSc/BEng degree in a science or technical discipline with a relevant postgraduate qualification a distinct advantage.
  • Have completed post-qualification quality and regulatory courses
  • Minimum ten years' experience in medical device quality and/or regulatory areas
  • In-depth understanding of both FDA Class II and EU MDD Class IIa medical device requirements and regulations.
  • Experience of implementing and maintaining ISO13485
  • Experience of hosting regulatory body, notified body and customer audits.
  • Interpersonal skills and professional skills to interact at all levels including senior management, contractors and colleagues.
  • People management and supervisory experience.
  • Experience of ICH E6 GCP requirements would be an advantage
  • Experience of using and/or specifying an eQMS system would be useful
  • Strong problem-solving and analytical skills


If you are interested in the above position please email a CV to careers@vitalograph.ie or by post to; HR Department, Vitalograph, Gort Road Business Park, Ennis, Co. Clare.
For more information on Vitalograph Ireland Ltd. Please visit www.vitalograph.ie

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