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QUALITY & REGULATORY ENGINEER

 

Company:

ICDS RECRUITMENT
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Job Reference Number

14565868

Client ID:

RI/EM12190
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Posted On:

Feb 6 2012

Location:

MEATH
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Job Type:

Permanent

Salary:

NEGOTIABLE
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Benefits:
  • SUBSIDISED CANTEEN
  • TRAINING / EDUCATION
  • CAR PARKING
  • PENSION / PRSA
Quality & Regulatory Engineerwith experience in a Quality Assurance or Microbiology role within a medical device company or Pharmaceutical field required for permanent role in Meath.

Position Summary:

This permanent position will be responsible for maintaining quality standards and ensuring regulatory requirements are met with regard to components, products and regulations.

Principle Responsibilities:

  • Generate and maintain technical files and all other relevant documentation required to comply with the Medical Device Directive 93/42/EEC and its relevant national transpositions and any other national or international regulations which apply.
  • To correspond / communicate with auditing bodies and regulatory authorities in all relevant matters.
  • To promptly reply to customer queries in relation to quality, technical and regulatory information for products manufactured & distributed.
  • To liaise with the relevant markets and update product registrations.
  • To liaise with the relevant component authorities and notified bodies of incidents and Field safety corrective action. Execution of field safety corrective actions.
  • To have the responsibility for developing and maintaining the risk management process in compliance to ISO 14971.
  • Assist with the overall compliance to the quality system.
  • Assist in the analysis of quality systems with the intention of designing, promoting and implementing systems and processes for continuous improvement and customer satisfaction.
  • Ensure the reporting of all quality activities is carried out accurately and in a timely fashion in keeping with the requirements of the management information system and S.O.P in place.
  • Carry out projects and duties as assigned by your manager in an efficient, timely and cost effective manner.
  • Ensure that excellent standards of quality are maintained throughout the business processes and monitor those standards on an ongoing basis.

Requirements:

  • Educated to degree or equivalent level in a Quality or Scientific discipline.
  • Must have experience in a Quality Assurance or Microbiology role within a medical device company or Pharmaceutical field.
  • Must have experience in regulatory affairs / regulations within a medical device company or Pharmaceutical field.
  • Must have a flexible approach to work and be capable of handling multiple priorities in a fast paced environment.
  • Strong attention to detail with a high degree of accuracy and excellent organizational and communication skills.
  • A passion for compliance and regulations .
  • Ability to work with and empathise with colleagues and customers from varied backgrounds and cultures.


www.icds.ie