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Job Details

Quality Engineering & Product Release Manager

Company: SciPro
Location: Dublin
Reference: HQ00050736
Closing Date: 23 Jan 17
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

Your responsibilities will include but not be limited to: * Manage direct reports including: develop and retain talent; establish and maintain clear roles and responsibilities; ensure adequate resource utilization. * Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements * Understand new regulations and guidelines, and implement systems and procedures to incorporate these new regulations. ...

Requirements:

Your responsibilities will include but not be limited to:

* Manage direct reports including: develop and retain talent; establish and maintain clear roles and responsibilities; ensure adequate resource utilization.
* Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements
* Understand new regulations and guidelines, and implement systems and procedures to incorporate these new regulations.
* Establish, track and respond to leading and lagging Quality Key Performance Indicators (KPIs).
* Provide Quality Engineering and Statistician contributions to cross-functional project teams that develop and/or transfer new diagnostic products under Design Control processes.
* Provide Quality Engineering and Statistician contributions for the approval and implementation of Design Changes to existing products and processes.
* Provide Quality Engineering and Statistician contributions and approval for product stability/monitoring programs.
* Provide Quality Engineering and Statistician leadership to CAPA and other investigations; maintain and develop functional expertise in: product and process technology, investigations, Root Cause Analysis, report writing, statistical data analysis, and implementation of actions arising from CAPA processes.
* Responsible to ensure that all released products meet the release testing processes, criteria and specifications. Responsible to understand how the release specifications trace to the product Design History File.
* Track and trend quality control and release testing data for all product lines; statistical process control engineering; trend alerts; Cp and CpK metrics.
* International travel (up to 20%) may be required.

Qualifications / Experience

* Primary degree qualification in a science, engineering or business discipline.
* Minimum 6 year experience in in vitro diagnostics or related industry.
* Design control and design transfer
* Process engineering
* CAPA and other investigations involving root cause analyses
* Successful implementation of continuous improvements to QMS
* Project management of change programs
* Building and leading effective teams, and highly motivated individuals

Skills and Behaviours

* Excellent verbal and written communication skills.
* In-depth knowledge of International Standards, GLP and GMP.
* Ability to successfully implement change.
* Ability to manage complex projects involving multiple functions.
* Strong technical and analytical/problem-solving skills
* Ability to collaborate with and influence groups in a positive, team-based environment

Apply for this job: Quality Engineering & Product Release Manager

Contact Information:

Address:  Head Office
4th Floor, 150 Leadenhall Street, London
EC3V 4TE
England
Tel:  +44(0)203 327 3072
Website:  Visit Our Web Site

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