Quality Control Manager

Requisition ID
2018-3720
Job Location(s)
Limerick Ireland
Travel
None
Company
Cook Ireland
Position Type
Full Time
Category
Quality
Education
Bachelor's Degree

Overview

The primary purpose of this position is provide leadership and direction to the quality control function within Cook Medical, this includes managing all quality control related activities by leading a team of Manufacturing Team Members with the support of Quality Control Supervisors, Team Leaders in a production environment. In addition, drive process/yield improvements to increase efficiency.

 

Reporting to: Director of Operations  

 

 

Find out more about Cook Medical here

Responsibilities

  • Responsible for quality control of medical devices within Cook Medical.
  • Develop short, medium and long term objectives for the quality control function to support overall company goals and objectives.
  • Monitor activities of the quality control group daily and provide direction to ensure that targets are attained to meet delivery service levels.
  • Prepare and implement capacity plans and maintain appropriate staffing levels necessary to meet business objectives.
  • Monitor productivity of group and individuals, recommend changes where necessary.
  • Ensure that a high standard of cleanliness is maintained in the manufacturing areas in order to control product bio burden.
  • Undertake people management responsibilities for the direct reports to this role, including but not restricted to, management of training and development requirements, carrying out performance appraisals and dealing with performance related issues.
  • Provide coaching and support to direct reports in their day to day roles and act as a point of escalation where necessary for specific issues that may arise.
  • Ensure open communication channels are maintained across all teams within the quality function, and that all relevant information is disseminated appropriately and in a timely fashion.
  • Work closely with other departments to meet delivery requirements.
  • Ensure compliance to all relevant quality system policies and procedures; facilitate internal and external audits.
  • Take ownership for assigned and team member customer complaints, CAPA’s, NCR’s, Audit Actions and work to determine root cause.
  • Monitor rejects, and rework to ensure they are kept to a minimum.
  • Participate in Product Transfer and Product Development cross functional teams to ensure readiness to implement new products into manufacturing; this will involve reviewing associated Change Requests and system procedures.
  • Liaise with other Cook manufacturing sites to facilitate inter-company communication to meet corporate operational goals.
  • Work with all areas, both inside and outside the remit of this role, to support smooth and efficient running of the Quality Control function.
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
  • Act as a designee for the Director of Operations for change control review as per Quality System Procedures.

Qualifications

  • Formal quality/engineering qualification and/or relevant quality experience preferably in a medical device industry environment.
  • Minimum 5 years previous experience in a quality management position desirable.
  • Knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
  • Good computer skills including knowledge of Microsoft® Office.
  • Willingness and availability to travel on company business.
  • Strong communication and inter-personal skills.
  • Strong business systems knowledge and experience working closely with IT and Finance.
  • Demonstrated ability to identify and implement improvement opportunities using structured project management techniques.
  • Excellent organisational and team building skills.
  • High self-motivation.

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