Job Description
Our client, a medical devices manufacturer based in Galway, now seeks a QA Engineer who will be responsible for establishing, implementing and maintaining the Quality System on site.
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 QA Engineer, NPI:
Promotes Quality Excellence within the company to customer requirements and the applicable regulatory standards.
Participates in new product/technology development and supports the QA activities as part of an overall project team.
Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes.
Makes appropriate decisions from test results and other process related findings.
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 QA Engineer, NPI:
Bachelor?s Degree in Engineering or Quality Assurance or similar technical discipline.
3+ years? experience in a similar Quality Engineering role in the medical device 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 / 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. 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.