Job Description
Our client, a Medtech manufacturer based in Galway, now seeks a Quality Engineering Supervisor who will manage quality operations activities and associated team in a world class manufacturing environment.
The successful candidate will partner with engineering and production to ensure that the transition of products into production from supplier sites, product approval and manufacturing scale up are in line with KPIs and all associated regulations.
Responsibilities of Quality Engineering Supervisor, shift role:
Leads Quality team and oversees all quality issues on shift cycle.
Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes.
Continually seeks to drive improvements in product and process quality.
Develops and executes required validations in line with regulatory standards to include equipment, process and product validations.
Conducts root cause analysis and implements corrective action in a timely manner.
Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action.
Creates and maintains company quality documentation.
Deals with suppliers and ensures their quality standards are in line with company SOPs and agreements.
Requirements for Quality Engineering Supervisor, shift role:
Bachelor's Degree in Engineering or Quality Assurance or similar technical discipline.
5+ years' experience in a similar Quality Assurance, Quality Assurance or Quality Engineering role in regulated industry.
Line management / supervisory experience is highly desirable.
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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