Senior Quality Engineer
|Contact Name:||Larry O’Leary|
required to manage; process audits, development of Quality Management system and associated documentation for our client, who manufacturers medical devices for global markets. This is a permanent role based in Dublin.
The successful candidate will be experienced in developing; CAPA, NCMR systems and control plans ensuring that performance and product quality conforms to company SOP's, customer and regulatory guidelines.
This is a lead role and will require the candidate to have people management experience.
Responsibilities of Senior Quality Engineer:
Strong working knowledge in the application of quality engineering tools and techniques with key emphasis on development of a dock to stock programme for key suppliers.
Support validation protocols, & amendments of the quality management system in ensuring compliance with the latest FDA directives/requirements within the Medical Device Sector.
Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
Responsibility for generating Quality Performance data with the goal in identifying opportunities for improvements (CAPA).
Development of validation projects
Support the implementation of Company Policies and GMP.
Support External/Internal audit program
Requirements of Senior Quality Engineer:
Degree in Science or Engineering or similar technical discipline.
5+ years' experience in Quality function, of which 3+ years experience in a Quality Engineering role with medical devices in FDA regulated environment.
Strong working knowledge of Quality Management Standard
Proven experience of Lean manufacturing / six sigma is highly desirable.
Please phone Larry on 01-2302400 / 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
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Key words; Customer Complaints, Investigations, Product Defects, Product Validation, Cleaning Validation, CAPA, Compliance, GMP, FDA, Kildare, Wicklow, Dublin, Leinster.