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TECH TRANSFER ENGINEER

 

Company:

PHARMA-BIO SERV
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Job Reference Number

14566609

Client ID:

RI/PBSV437
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Posted On:

Feb 7 2012

Location:

MUNSTER, CORK
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Job Type:

Contract/Permanent

Salary:

COMPETITIVE SALARY/RATE
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At Pharma-BioServ, we are recruiting a Tech Transfer Engineer to join our existing team of consultants within the R&D department of our medical device client based in Cork.

Role

  • Produce and maintain quality process specifications
  • Document and maintain all relevant Quality assurance sections of Device Development History File and DMR as directed by Data Management.
  • Compile and execute validation protocols for new product/processes and software.
  • Provide QA input for URS for new technology / equipment.
  • Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques
  • Liase with R&D to ensure CTQs are agreed and documented for all NPD.
  • Lead Design for Inspection activities for all NPD
  • Lead QA input in Design for Manufacture activities on site.
  • Ensure correct use of statistical QA methods into the production environment,
  • Ensure compliance with Documented Quality system, as per SEP 180 i.e. FDA QSR’s and ISO 13485/9001.
  • Provide technical assistance to carry out problem analysis/complaint investigation and define through negotiation effective corrective actions.
  • Monitor and establish scrap and reprocessing rates as for all NPD.
  • Review and approve product, gauge, tooling and fixturing drawings.
Experience

  • A degree level or similar qualification in mechanical or industrial engineering
  • Minimum 5 years experience in a manufacturing engineering or quality role within a regulated industry.
  • Proven ability to successfully introduce new product development in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
  • Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
  • Proven experience and training in Mechanical Engineering processes.
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 021-4619034/0867952010 for an initial and confidential discussion.