Job Description
Our client, an innovative Medtech company based in Galway, now seek an experienced Quality Systems Manager to lead associated team working within Quality systems, with responsibilities for Quality Management, Internal and External Audits in FDA regulated cGMP manufacturing environment.
The successful candidate leads/manages inspection activities of the Quality System related to regulatory agencies and/or notified bodies, across numerous global markets.
Responsibilities for Quality Systems Manager
Lead ISO/MDD quality systems standards, constantly promoting awareness of best industry practices.
Leads/manages internal audits of the Quality System that evaluate the adequacy and compliance of systems; and identify areas of potential noncompliance or improvements.
Active member and lead within the audit team, participating in audits of varying complexity. Audit assignments are technical and complex in nature.
Performs timely and adequate effectiveness checks and monitors corrective action progress for audit non-conformities.
To provide assistance and support to the engineering and operational functions on quality system requirements.
Champions continuous improvement and innovation from a quality system perspective.
Collect and analyze business/quality system process data from different parts of the company.
Lead problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Assist with development and maintenance of department metrics
Requirements for Quality Systems Manager
Honours Bachelor's Degree (NFQ level 8) in Science, Engineering or similar in related discipline.
8+ years' industry experience, of which 6+ years' relevant experience in Quality Assurance, Quality Systems or Quality Engineering role resolving quality assurance issues in line with a Quality Management System.
People management experience
Proven experience in working in audit facing role, managing both internal and external audit preparation and audit process.
Good interpersonal skills and organisational skills.
Excellent attention to detail.
Please contact on Larry on 01-2302400 / 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. www.rftgroup.ie / www.meddevicejobs.ie
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