Quality Management System Administrator

-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. Manage change of documents.

-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.

-Aid in the manufacturing of devices (periodically) from planning to signing off final batch record documentation.

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.

-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).

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.