Our client, a global leader within the Medical Device industry, are looking to recruit a Quality Manager on a permanent basis.
- Supporting continued development and maintenance of consistent Quality management processes
- Perform as an active engaged member of the Galway Quality Assurance/R&D Management team.
- Recruit, develop, manage and coach all employees within the department towards sustainable performance levels.
- Define clear goals and objectives for staff as applicable. Develop talent within the function. Coach/Mentor as applicable.
- Execute and monitor annual Quality Objectives for department & the wider Quality organization as required. Define departmental goals/objectives
- Implement new programs, test methods, instrumentation, and procedures by investigating alternatives; developing and performing parallel testing; monitoring progress. Define KPI?s to sustain and monitor performance and drive improvement.
- Drive Role Mandate definition within the DA test/functional group and expand out to key stake-holding departments both within and outside of Quality Org
- Represent the DA lab function in all internal/external audit activities approve audit reports and ensure that all defined Corrective and Preventive Actions are complete and timely.
- Implement a Visual Management system within the lab to aid in branding and communication
- Develop and maintain annual cost center operating budgets and departmental goals?strategic planning of resources
- Ensure compliance with safety, regulations , QSR, ISO standards, Quality Business Systems and Corp Policies
- Ensure the lab quality system is continuously improved and ensuring adherence to Lab Accreditation Standard?s?Drive adaption of ISO 17025 within applicable labs across the site.
- Managing the Design labs in terms of detail planning, recruiting of laboratory personnel, qualification of instruments, etc., provide all necessary Laboratory support to ensure successful and on-time completion of testing.
- Managing the laboratory in order to support routine plant operations in terms of new product development testing. Support QA, R&D, process engineering and other clients in case of special projects.
- Implementing processes and procedures to ensure on-time delivery of all testing in compliance with GMP, the relevant regulatory guidelines/industry standards and the relevant local and global safety guidelines. Ensuring compliance with all Lab Equipment Installation/validation
- Investigating OOS/OOT results and implementing CAPAs as required.
- Contribute to global projects as required, with the aim of harmonising existing test methods and processes.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
- 5+ years relevant experience in Quality Assurance or a quality related discipline with a Level 8 Degree in Quality, Engineering and/or Science discipline (eg: Chemistry/Biology/Biochemistry) is required.
- Previous people management experience in a medical device environment is required supervisory experience within a Laboratory a distinct advantage
- Demonstrated project leadership ability with analytical problem solving skills. Prioritization skills.
- Knowledge of Quality/product/design/manufacturing/test systems.
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