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QUALITY ENGINEER

 

Company:

PHARMA-BIO SERV
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Job Reference Number

14566606

Client ID:

RI/PBSV503
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Posted On:

Feb 7 2012

Location:

CORK, MUNSTER
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Job Type:

Contract/Permanent

Salary:

COMPETITIVE SALARY/RATE
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At Pharma-BioServ, we are recruiting a Quality Engineer to join our existing team and work as a consultant within the R&D department of our medical device client based in Cork . This is an initial 12 month contract role.

Role
  • Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new technologies/processes.
  • Introduce new technologies in parallel for new product introductions and current processes to ensure compliance to all regulations/specifications.
  • Lead and manage inspection strategy for the site and maintain detailed project plans.
  • Document and maintain in good order all relevant Quality assurance Design Controls as directed by Data Management.
  • Generate URS for new technology / equipment as a part of the Asset Life Cycle.
  • Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risks during development/implementation activity.
  • Lead overall inspection strategy for inspection/compliance activities for all new products
  • Lead QA input in Design for Manufacture activities on site related to inspection.
  • Ensure compliance with all Documented Quality systems, as per SEP 180 i.e. FDA QSR’s and ISO 13485/9001 requirements etc. during day to day and assigned audit/CAPA activities
  • Provide technical assistance to carry out problem analysis/complaint investigation related to product inspection and data analysis.
Experience

  • Degree qualified in Science or Engineering discipline.
  • Minimum 5 years experience in a Quality Engineering role.
  • Experience within Process Excellence through Green Belt/Black Belt Trainings.
  • Proven Experience relating to FMEAs
  • Proven knowledge and ability regarding equipment and process validations within a regulated industry.


Pharma-Bio Serv is a Regulatory Compliance and Validation Consulting Service provider, with locations in Cork Ireland, Philadelphia, USA and Puerto Rico. Over the past 18 years, we have established a broad base of compliance related services, currently focused on the effective and optimized leveraging of Quality Risk Management Strategies. Our goal is to provide our partners with insightful and robust compliance solutions that have a direct impact on your business.

To apply for this role, send your updated CV to smanley@pharmabioserv.com or call Sarah Manley on 021-4619034 for an initial and confidential discussion.