Quality Operations Specialist
|Contact Name:||Larry O’Leary|
Our client, a medtech manufacturer based in Galway, now seeks a Quality Operations Specialist who will manage new product development (NPD) and new product introduction (NPI) activities, and supports the QA activities as part of an overall project team.
The successful candidate will Partner with R&D and Process Engineers to ensure that the transition of products through R&D and sister sites, product approval and manufacturing scale up are smooth, timely and cost effective.
Responsibilities of Quality Operations Specialist:
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 Operations Specialist:
Bachelor's Degree in Engineering or Quality Assurance or similar technical discipline.
3+ years' experience in a similar Quality Assurance, Quality Assurance or Quality Engineering role in regulated industry
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. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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Key words: QA Engineer Quality Engineer, Quality Engineer, Validation, NPI, Quality Management, Quality Assurance Manager, Process Validation, Auditing, Supplier Quality, Galway, Athlone, Roscommon, Medical Devices, Pharmaceutical.