Job Description
Our client, a Medtech company based in Cork, now seek a Quality Systems Manager to maintain and expand the quality management system along with supporting new product development.
Scope of this role includes:
- Act as management representative with responsibilities as outlined in ISO 13485.
- Manage company’s preventative maintenance and calibration schedules and plans.
- Management of Internal auditing programs and vendor management activities including critical vendors audits.
Responsibilities for Quality Systems Manager:
Manages, plans and documents all routine product testing to ensure continued compliance of products.
Manage and drive project tasks to ensure timely completion of QMS project milestones.
Lead the integration of the EU MDR requirements into the existing ISO 13485 Quality Management System.
Prepare for and document company meetings such as Management Review, Post Market Surveillance and Quality Monthly Meetings.
Maintain design history files in accordance with the company's product development process.
Liaison with the Notified Body, FDA and Competent Authorities as required.
Lead CAPA related activities and associated tasks.
Ensure product inspections take place in line with company procedures, manage any Deviations, NCPs or MRBs which may arise.
Trend all Quality Data as required, identify and implement changes or improvements to existing systems.
Monitor global regulatory/quality system changes, guidelines or trends, complete gap analysis plan, advise or implement changes to ensure compliance.
Requirements of Quality Systems Manager:
Bachelors Degree qualified in STEM.
10 years’ experience in quality role of a medical device company.
Lead auditor certification (IRCA or ANAB).
Established understanding and track record of ISO 13485, 21CFR820, ISO 14971 and MDD93/42/EEC.
Experience with European Medical Devices Regulations (EU-MDR), Regulations (EU) 2017/745.
Lead auditor certification (IRCA or ANAB).
Experience of clinical trials or clinical investigations is preferred.
Strong ability to manage critical projects as part of an interdisciplinary team.
Excellent problem solving, oral and written communication skills.
Ability to work as part of multi-disciplinary team of clinicians, engineers and senior management.
Please contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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