Description:
ROLE TITLE: Quality Engineer / Validation
1. Job Purpose:
Reporting to the Business Unit Quality Manager/Staff Validation Engineer, this role is responsible for establishing and ensuring adherence to standardized validation best practices, whilst ensuring that company and external regulatory, quality, and compliance requirements are met.
2. Responsibilities:
Main areas of responsibility:
− Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
− Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
− Runs /Manages complaint investigation and resolution of same
− Designs and develops validation documentation to support business continuity, new process/product introductions and process improvement requirements
− Implementation and co-ordination of the change control process promotes timely approval of all supporting documentation
− Implement J&J policies and procedures
− All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
3. Education and Experience Required for Role
Essential:
− A Bachelor’s degree from accredited college
− 3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry.
Desirable
− Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets.
− Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
− Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
− Ability to demonstrate standards of leadership – Managing Complexity/CredoValues/ Innovations/Customer focus.
− Flexible
− Team Player
− Good Influencing Skills
− Project Management Skills
− Good generalist
− Good communication skills
Note:
Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Description.