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QUALITY & REGULATORY ENGINEER
Company:ARCROYAL |
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Job Reference Number |
14571339 |
Client ID: |
RI/JD103 |
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Posted On: |
Feb 21 2012 |
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Location: |
LEINSTER, MEATH |
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Job Type: |
Permanent |
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Salary: |
NOT DISCLOSED |
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Benefits: |
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ArcRoyal is one of Ireland's fastest growing Medical Device companies. With a 20 year history of strong growth, innovation and customer service excellence, ArcRoyal is continuing its expansion into Europe and is looking for top quality candidates for the following positions.
JOB TITLE: Quality and Regulatory Engineer
SUBSIDIARY: ArcRoyal
REPORTS TO: Quality Manager
LOCATION: Virginia Rd, Kells, Co 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.
1. Principle Responsibilities:
1.1.1 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 ArcRoyal.
1.1.2 To correspond / communicate with auditing bodies and regulatory authorities in all relevant matters relating to ArcRoyal.
1.1.3 To promptly reply to customer queries in relation to quality, technical and regulatory information for products manufactured & distributed by ArcRoyal.
1.1.4 To liaise with the relevant markets and update product registrations.
1.1.5 To liaise with the relevant component authorities and notified bodies of incidents and Field safety corrective action. Execution of field safety corrective actions.
1.1.6 To have the responsibility for developing and maintaining the risk management process in compliance to ISO 14971.
1.1.7 Assist with the overall compliance to the quality system.
1.1.8 Assist in the analysis of quality systems with the intention of designing, promoting and implementing systems and processes for continuous improvement and customer satisfaction.
1.1.9 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.
1.1.10 Carry out projects and duties as assigned by your manager in an efficient, timely and cost effective manner.
1.1.11 Ensure that excellent standards of quality are maintained throughout the business processes and monitor those standards on an ongoing basis.
1 Education / Experience
2.1 Educated to degree or equivalent level in a Quality or Scientific discipline.
2.2 Must have experience in a Quality Assurance or Microbiology role within a medical device company or Pharmaceutical field.
2.3 Must have experience in regulatory affairs / regulations within a medical device company or Pharmaceutical field.
3 Personal Characteristics3.1 Must have a flexible approach to work and be capable of handling multiple priorities in a fast paced environment.
3.2 Strong attention to detail with a high degree of accuracy and excellent organizational and communication skills.
3.3 A passion for compliance and regulations.
3.4 Ability to work with and empathise with colleagues and customers from varied backgrounds and cultures.
