Job Description
Our client, a Medtech manufacturer based in Galway, now seeks a Quality Assurance Manager who will manage quality operations activities and associated team in a FDA regulated cGMP manufacturing environment.
The successful candidate will lead the Quality Assurance team and their performance management, while overseeing all quality issues within operations, including; NPIs, product and process transfers from supplier sites, new equipment solutions, manufacturing scale up in line with KPIs, internal and external audit management in line with QMS and regulatory compliance etc.
Also, this hire will lead/manage inspection activities of the Quality System related to regulatory agencies and/or notified bodies, across numerous global markets.
This hire will exercise significant stakeholder management; partnering internally with: operations, engineering, R&D, regulatory, supply chain; and externally with supplier sites, auditors and customer satisfaction / post marketing.
Requirements for Quality Assurance Manager:
Bachelor's Degree in Engineering or Quality Assurance or similar technical discipline.
8+ years' experience in a similar Quality Assurance, Quality Assurance or Quality Engineering role in regulated industry.
2+ years line management / supervisory experience is required.
Detailed knowledge of the regulatory environment, i.e. FDA, cGMP, ISO13485, etc.
Proven experienced with CAPA, deviations and leading investigations.
Experience in conducting audits and dealing with regulatory bodies.
Project management experience is desirable.
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. www.rftgroup.ie
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