Quality Manager

Position Summary

The Quality Manager develops, maintains and communicates laboratory quality assurance systems by ensuring that laboratory procedures are being performed within specified quality guidelines. The main purpose of these activities is to ensure that the quality requirements are implemented adequately and the quality system is reviewed, improved and updated.

Also to ensure that the in-process reworks are reduced and accuracy of results and customer satisfaction is improved. The incumbent directly reports to the Regional Quality Manager.

Essential Functions

and Responsibilities ● Develop, establish and maintain all quality related documents (Manuals, Procedures, Work Instructions, Charts, Guidelines). ● Prepare internal quality audit programs and conduct the internal audits as per approved schedules in accordance with pertinent quality documents and prepare all the corresponding documents and reports.

● Check randomly and systematically, that the quality system is documented, effective, updated and understood and adhered to by the staff. ● Monitor the quality activities and evaluate the agreed corrective action for effectiveness. ● Participate in the implementation of internal quality control programs, evaluation of the results and in the establishment of the internal repeatability and reproducibility of standard methods.

● Carry out thorough investigations of quality failures, complaints and make recommendations for correction and improvement as necessary. ● Maintain the external standards and update the method database on an ongoing basis. ● Manage the internal and external calibration program and review records. ● Establish control limits for all the tests and determine uncertainty of measurement where applicable.

● Participate in customer, regulatory and Accreditation Body audits and maintain the approval status. ● Organize management review and IQA meetings and prepare all relevant information (e.g. internal audit findings, external assessments, quality investigations, quality checks, quality charts, complaints etc). ● Conduct in-house training sessions on total quality management, the quality system and related issues.

● Analyze and report to the management the status of external proficiency program results, follow up to ensure close-out of any non-conformances and conduct follow-up audits. ● Responsibility and authority in conjunction with the Lab Director: (a) to cease specific analyses when evidence from the quality system indicates the process is not in control and the quality of the results are compromised as a result of the non-conformances and (b) to authorize the restart of work and communicate the resumption of work to Corporate Sales and Quality groups.

● Maintain knowledge of LIMS that is required to complete job responsibilities. ● Other related duties as assigned. ● At any time, the incumbent must behave and operate in an ethical and Code of Conduct compliant manner.