MedicalCareers

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Quality Management System Administrator (Northern Suburbs -JHB)

Job Overview

More Information

A medical devices company has an opportunity for a quality administrator to assist in achieving all the company’s quality objectives. (Important to have  relevant degree and sterilisation knowledge)

 

  • Organize, track, and maintain information concerning the various aspects of the Quality Management System (QMS)
  • Coordination and follow-up of procedures and other documentation associated with ISO13485:2016 including the management and coordination of the development of new documented processes required for continual improvement.
  • Timeous document, monitoring and reporting on the Corrective / Preventive Action, non-conforming product, and Complaints systems
  • Participate and perform internal audits as per the internal audit program
  • Supplier audits when necessary
  • Responsible for control of internal and external documents
  • Champion organizational goals (quality objectives and key process indicators KPI’) and values
  • Support the Group RAQA Manager and/or other team members in various projects as assigned
  • Support and supply data including statistical analysis of data for management review, take effective meeting minutes and track tasks
  • Responsible for training of all employees concerning the QMS
  • Implement the document change process effectively including the withdrawal, re-issuing and disposal/obsolete of documents and maintenance of the internal document register.
  • Management of the manufacturing of devices from planning to final sterilization and transport into the warehouse including reporting of manufacturing statistics. (NOTE: Periodic manufacturing)
  • Management of distributors in terms of product complaints, product returns and contractual requirements for quality related documentation/processes.
  • Management of maintenance and calibration of manufacturing equipment as required.
  • Management of device manufacturing suppliers in terms of approvals and evaluation.
  • Administration of the Human Resources Process.

Experience and Qualifications

  • Bachelor’s degree in a quality related discipline or bachelor’s degree in another discipline with quality experience
  • 3 years minimum experience in document control and QMS experience
  • Expert level knowledge of ISO 13485:2016
  • Preferable: CE MDD and MDR knowledge
  • Candidate must possess intermediate usage skills with Microsoft Office (Outlook, Excel, PowerPoint, etc.)
  • Self- disciplined professional working environment
  • Ability to compile routine reports and correspondence, ability to speak and write effectively and professionally and effectively work with diverse team members
  • Good working knowledge of quality requirements and management systems for the manufacture and distribution of medical devices
  • Excellent written, verbal and communication skills
  • Attention to detail
  • Ability to prioritize time efficiently, excellent problem-solving skills, adaptability to change with conditions and circumstances is essential in successfully performing this job
  • Capable of working independently and willing to take initiative when discrepancies are found in the system
  • Ability to learn new programs

Language Skills:

  • Ability to read, analyse and interpret general business periodicals, professional journals, technical procedures, or government regulations.
  • Ability to write clear and concise reports, business correspondence, procedures and/or work instructions.
  • Ability to effectively present information and respond to questions from groups of management, associates, customers, and public.

Reasoning Ability:

  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Must have experience in medical device manufacturing and related concepts of working in a cleanroom.
  • Must have experience in sterilization of medical devices (EO sterilization, compliance to ISO 11135).

Send your updated CV  to Vicki  at vicki@medicalcareers.co.za

Subject : Quality

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