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Quality Manager Ostomy Plant

Job Title: Quality Manager Ostomy Plant
Contract Type: Permanent
Location: Mayo
Industry:
REF: 89380
Job Published: about 1 year ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

Quality Manager Ostomy Plant
Our client, a medical device company in Mayo are currently looking to recruit a Quality Manager Ostomy Plant for their site.


Summary
  • The Quality Assurance Manager provides Quality leadership for the Ballina Ostomy Plant, and contributes to the growth and profitability of the company.
  • These provisions include the necessary monitoring, feedback and corrective action mechanisms to ensure continued compliance to both system provisions as well as product (device) requirements.
Responsibilities
  • Lead and develop the Ostomy Quality Team
  • Develop and advise on the continued development of quality systems and procedures for the Ostomy area, including the development of product specifications / drawings / quality plans in conjunction with NPC personnel and the development of Master Validation Plans as required.
  • Provide leadership in change management and risk assessment, specifically process risk and capability analyses
  • Conduct, lead, or direct Ostomy product complaint investigations.
  • Coordinate the Ostomy business Corrective and Preventive Action (CAPA) program
  • Participate in the internal audit program
  • Provide project leadership for implementing continuous improvement projects
  • Provide leadership and resources for verification and release of finished goods into distribution
  • Ensure Ostomy Quality team is trained to FDA QSR and ISO 13485 / 14971 requirements
Essential Functions of the Role
  • Personnel Staffing and Management
  • Problem Solving and Analysing
  • Project Managing (includes AFE process)
  • Fiscal Managing (includes budget preparation)
  • Goal Setting
  • Communicating/Leading
  • Processes Improvement
Qualifications
  • Degree in Physical Science, Engineering, or other related discipline
  • 10 years' experience in a quality engineering/systems role including people management experience.
  • Knowledge of applicable foreign and domestic regulations
  • Knowledge of quality engineering tools and statistical quality control techniques
  • Knowledge of quality auditing techniques
  • Knowledge of process validation techniques
  • Knowledge of project management skills
  • Basic knowledge of sterilization
For further information on this Quality Manager Ostomy Plant role in Mayo please contact Bimi Felix on 0868395533 / bimi@hero.ie
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