Quality Manager

Limerick  ‐ Onsite
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Keywords

Description

I have an immediate opening for a Quality Manager with an exciting medical device start up company in Limerick. This is an excellent opportunity to join company who are looking to implement Quality Systems and set up a robust quality approach, for an organisation with steep growth plans.

The Quality Manager promotes the creation of a culture of Quality throughout the plant and ensures compliance with company quality systems, policies, procedures and practices as well as with all local, national and regional regulatory requirements. The successful candidate will need to be capable of leading the quality decisions locally and managing the expectations and reporting out to quality management in the USA.

RESPONSIBILITIES:
- Responsible for the implementation of the quality system in the Limerick This will include the identification and prioritizing of quality policies and defining the objectives necessary to achieve implementation and maintenance of an ISO certified quality system in the facility.
- Ensures quality representation on new product development teams and design control compliance to ensure instrument, software and reagent designs are appropriate for their intent and purpose and in compliance with regulatory requirements.
- Responsible for ensuring the production and release of quality products in compliance with all manufacturing procedures.
- Management of internal and external non-conformances including the CAPA system
- Act as the main contact for all internal and external quality related matters.
- Preparing and disseminating quality metrics and project progress reports in a timely fashion.
- Writing and reviewing procedures, implementation of new procedures and policies.
- Training all staff in ISO, GMP and other Quality Systems training

EDUCATIONAL REQUIREMENTS:
Relevant 3rd level qualification (Scientific, Engineering, Quality Assurance, Quality Control)

EXPERIENCE:
- A minimum of 7 years' quality experience in an instrument development and production industry including expertise in ISO 9001, ISO 13485 and 21 CFR Part 820.
- At least 5 years' experience in a relevant Managerial or Supervisory position
- Experience dealing with regulatory authorities
- Auditor training and experience, certification is preferred
- LEAN/ Six Sigma certification is an advantage for this position
- Excellent communication and interpersonal skills enabling effective cross functional and cross site teamwork
- Ability to work under pressure and to tight deadlines

This really is a brilliant opportunity to join a rapidly growing company that will offer fantastic exposure to new processes and opportunities for career progression. If you are interested please apply directly to this advert or contact Derek Sheridan on for further information
Start date
12/2014
From
Real Staffing
Published at
28.11.2014
Project ID:
815239
Contract type
Permanent
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