Design Services Quality Manager
|Job Title:||Design Services Quality Manager|
|Job Published:||about 2 years ago|
Our client, a medical device company in Galway are currently looking to recruit a Design Services Quality Manager for their site.
Duties & Responsibilities:
? The Quality manager is responsible for and will provide direction for processes within the Design Assurance Laboratory and other assigned areas as applicable
? 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 centre 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.
Qualifications & Experience:
? A minimum of 9 years relevant experience in Quality Assurance or a quality related discipline with a Level 8 Degree in Quality, Engineering and/or Science discipline (e.g.: 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.
? Excellent interpersonal, oral, presentation, and written communication skills.
? Green/black belt Lean and/or Six Sigma preferred.
? Demonstrates Leadership Expectations in their work. An ability to Lead, Influence and Inspire.
? An ability to Shape outcomes by Engaging with personnel to encourage Innovative thinking?promote an Achievement ethos by delivering results to the highest standards.
? Effective Communication: Foster Open Communication. Clearly communicates both verbally and in writing; encourages an open exchange of information and viewpoints; actively listens to others. Facilitate open discussion to ensure that everyone?s viewpoint is heard. Encourage the open exchange of information and viewpoints.
? Performance Management: Foster High Performance Culture (applies to People Managers). Ensures that employees have clear performance expectations; provides targeted coaching and constructive feedback; conducts timely and candid performance evaluations; supports meaningful development activities. Ensure that employees have clear performance expectations. Understand the characteristics of high-impact feedback. Offer targeted and behaviour-based coaching. Translate development goals into actionable plans. Provide resources to support development plans.
? Business Acumen: Uses business data to measure business performance; makes recommendations regarding resource utilization based on sound cost/benefit analyses.
? Innovation: Contributes innovative ideas that lead to positive business results encouraging and adopting new ways of looking at problems, processes and solutions.
For further information on this Design Services Quality Manager role in Galway please contact Cliona O?Malley on 091730022 / email@example.com
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