Cache of job #13654198

Job Title

Principal Quality Engineer (Micro)

Employer

Hartley People Recruitment

Location

Waterford, Wexford

Description

Our client, an award winning manufacturing company are looking for a Senior Quality Engineer to join their team. This is an opportunity to join an established company in a challenging and rewarding role with excellent opportunities for personal development. The Role: The co-ordination and control of sterilisation, biocompatibility (finished product and raw materials) and environmental monitoring (including all cleanrooms. Responsible for the training of the quality inspectors in relation to sterile release and for overseeing this approval. Playing a role in the plant annual objectives. Ensure continued compliance with all Regulatory Standards. These includes: ISO 11135. ISO 10993. ISO 14644. ISO 14698. ISO 11607. ISO 13485. FDA QSR. ISO 14000. Ensuring continued compliance with DMR. Monitor all aspects of product and paperwork preparation for sterilisation and approval and environmental monitoring in the manufacturing process for compliance to ensure quality product is shipped to customer and provide: Trend analysis of data. Potential improvements for review based on the trends. Areas for improvement to senior management. Review and propose changes to sampling plans based on trend analysis andchanges to the system. Ensuring continuous compliance with the following: Related sterilisation validation standards. Related biocompatibility and environmental standards. Conduct training in sterilisation and microbiological and related procedures as required. Drive the site validation for sterilisation, including all liaisons with the contract steriliser. Interacting and presenting sterilisation and microbiological documentation during FDA, NSAI, Corporate and customer audits. Carry out a documented monthly evaluation of cleanrooms. Support any RCA meetings related to sterilisation and /or environmental monitoring to ensure that internal and customer concerns are handled and dealt with in an appropriate manner. Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner Sterilisation and cleanroom Validations. Product adoptions to the LRI sterile cycle. Engineering Change Order (ECO. Request for Corrective Action (RCA. Request for Technical assistance (RTA. Material Review Request (MRR) – must countersign all related to sterilisation and environmental monitoring. Internal Audits. Failure Mode Effect Analysis (FMEA. Variation Permits (VP. Work on specialised projects as required. Ensure the company behavioural standards are adhered to, setting the example yourself for your direct reports. Project meeting attendance as required. Attend and participate in daily cell meetings. Preparation of information for PMR and Management Review meetings. The Person: Engineering or science Degree. Qualification in microbiology is preferable. A Six Sigma qualification will be a distinct advantage. Good PC skills. 1-3 years experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment. Ability to communicate and work with people inside and outside the department. Good communicator (written and oral. Ability to train and lead where required. Ability to co-ordinate, plan and organise in a timely manner. Knowledge of engineering theories and methods, demonstrating an aptitude for analysis and problem solving. Rigorous attention to detail. Ability to work independently and without direct supervision while maintaining adherence to timelines is fundamental to the role. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Pairic on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Analytical Chemist, Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, Formulation Scientist, Development Technologist. This job originally appeared on RecruitIreland.com.

Date Added

2623 days ago

Apply