QA/RA Manager - Expired
|Job Title||QA/RA Manager|
|Salary||€0.00 per annum + Competitive Salary|
|Location||Clare, Republic of Ireland|
|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.
- 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 email@example.com 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