Posted

29 days ago

Description

Overview

The primary purpose of this position is to lead a team of QC Manufacturing Team Members in a production environment.

 

Reporting to: Quality Control Manager  

 

 

Find out more about Cook Medical here

Responsibilities

  • Responsible for Quality Control of medical devices within Cook Medical including inspection of raw materials, in-process product, finished and sterilized devices.
  • Ensure that the work done by quality control personnel is in compliance with the requirements of the quality system.
  • Prepare or review SOP’s manufacturing/quality control instructions, which are required by the quality team.
  • Ensure that a high standard of cleanliness is maintained in the manufacturing areas in order to control product bio burden.
  • Ensure that changes to relevant procedures/instructions are relayed to those affected in production.
  • Ensure that training needs of employees in the QC area are constantly reviewed and that required training is given as appropriate.
  • Monitor employee performance and carry out performance appraisals with employees.
  • Maintain excellent communication channels with the production team and with other departments.
  • Work closely with other departments to meet delivery requirements.
  • Take ownership for assigned customer complaints, CAPA’s and determine root cause.
  • Monitor rejects from quality control processes and disposition through MRB process
  • Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

  • Level 8 in Manufacturing Engineering or related discipline preferable.
  • Minimum 5 years previous experience in a supervisory position desirable.
  • Strong communication and inter-personal skills.
  • Knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
  • Knowledge of Lean Manufacturing desirable
  • Good computer skills including knowledge of Microsoft® Office.
  • Excellent organisational and team building skills.
  • High self-motivation.
  • Willingness and availability to travel on company business.

#

Source: Cook Group