Quality Assurance Manager
|Contact Name:||Larry O’Leary|
Our client, an OEM Medtech manufacturer based in Galway, now seeks a Quality Assurance Manager who will manage quality operations activities and associated team in a world class manufacturing environment.
The successful candidate will lead the Quality team and their performance management, with oversight for all quality issues within operations area, including; NPIs, process & product transfers from supplier sites, manufacturing scale up are in line with KPIs, managing internal and external audit process and ensuring compliance with QMS, SOPs and regulatory bodies.
This hire will exercise significant stakeholder management, internally in partner with engineering and production; and externally with supplier sites, auditors and customer approvals/satisfaction.
Requirements for Quality Assurance Manager role:
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.
Line management / supervisory / people management 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 / firstname.lastname@example.org
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
Follow us on: Facebook, Linked-in, twitter