Quality Engineer required for leading Medical diagnostics company. Must have strong VALIDATIONS, CALIBRATIONS as well as projects experience

• Continuously strive to provide the required service level to both internal and external customers
• Ensure prompt attention of the Site Quality Head in areas of risk, which may have an adverse effect on product quality/performance and/or safety
• Issue an area report to the Site Quality Head as appropriate
• Participate, input and approve relevant ERs, Investigations, Internal Audits associated with Validation and calibration area
• Lead assessment, impact analysis and implementation plans for new/updated Q Documents for area of responsibility
• Assist in and become involved in cost saving ideas and assist in compiling information for annual budgets
• Ensure that activities are completed within budgeted guidelines e.g. waste levels, per plan requirements
• Lead the rollout of the S-VMP and on an ongoing basis for all site validations
• Ensure all aspects of activity within the Validation and Calibration group adhere to required policies and procedures, including safety and training
• Ensure that the plant meets the quality requirements of its customers with respect to Validation and Calibration, ISO 9001:2000/ISO 13485/ISO 13488, In Vitro Diagnostics Directive, Division & Corporate Policies and other external standards
• Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective
• Develop and be responsible for all aspects of Q01.04.001, FMEA Procedure at the site
• Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues
• Assist in the development of the existing Validation Program to ensure continued compliance to the necessary regulations
• Collate and Report on relevant Validation data/matrices

Desired Education:

• 2-3 years experience in a Health Care Company preferably working with diagnostics.
• BSc / BEng -  Chemistry or Life Science discipline, or a qualification in Quality Management. This will provide the foundation necessary to understanding the principles of operational Quality
• Or: BSC Honours degree with calibrations