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QUALITY MANAGER - HEALTHCARE
Company:ICDS RECRUITMENT |
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Job Reference Number |
14297855 |
Client ID: |
RI/AM11159 |
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Posted On: |
Mar 18 2010 |
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Location: |
MEATH |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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In this role you will be responsible for Quality Assurance and managing all resources dedicated to that function. Coordinate Regulatory Affairs for the relevant EMEAA markets.
Principle Responsibilities will include :
Maintain the quality system in compliance with Annex V, Annex VII and Article 14 of the Medical Device Directive 93/42/EEC, and relevant EMEAA regulations.
Ensure that satisfactory standards of quality, sterility, and biological safety are maintained within confines of Quality Department budget and ensure the Quality System at all times meets ISO 9000/EN 46000/ISO 13485 series of standards and any other standards which may apply from time to time.
Act as Quality System Management Representative as outlined in ISO 9000/EN 46000/ISO 13485 and any other applicable Quality Management Standard.
Ensure that responsibilities of the company, as the Authorised Representative for the company, are fulfilled to meet the requirements of Article 14 of the Medical Device Directive and the Technical Contract.
Ensure Class I and Class IIa products meet all the relevant provisions of the Medical Device Directive prior to CE marking and continue to do so for as long as they are CE marked.
Ensure that all specifications, processes, materials and products are appropriate for their intent and purpose and in compliance with approved, agreed requirements.
Ensure all sampling plans and test methods and procedures are appropriate for their intent and purpose.
Identify and prioritise policies and objectives necessary to achieve and maintain quality standards as committed to in the quality policy.
Ensure contributions are actively encouraged from Quality Department for cost improvement and continious improvement. Ensuring all projects and reports are completed in an accurate and timely manner.
Inform the Notified Body of any significant changes in systems or procedures which could potentially affect registration.
Ensure all resources of personnel and equipment allocated to the Quality Department are utilized efficiently and within the confines of Quality Department Budget.
Promote and maintain safety, health and welfare in accordance with regulatory and company policies and procedures.
Lead, motivate and develop your team in line with company policy and HR strategy including recruitment, training and performance management.
Communicate effectively and work with colleagues and customers from diverse backgrounds and cultures.
Prepare and present annual budget for the department and manage activities within the limitations of the approved budget.
Interested applicants for this position should have:
Educated to degree or equivalent level in a Scientific Discipline or similar.
At least 3 to 5 years' experience in Quality Assurance, or Microbiology in the Medical Device or Pharmaceutical field.
Experience with sterilization systems and validation.
Minimum of 5 years' management experience demonstrating strong people management skills.
Excellent presentation and communication skills to individual and group audiences (these may be direct reports, customers, suppliers or outside agencies).
Ability to analyse information, draw conclusions and make sound and timely decisions.
Ability to deal with ambiguity, rapidly prioritise and respond to change quickly.
A passion for continually improving processes with a focus on results.
Financially astute and bottom line driven with a good aptitude for numbers.
Demonstrated people management skills, a strong team builder with good strategic perspective who possesses strong influencing and communication skills.
