**Date**:28 May 2024**Location**: Kamunting, 08, MY**Company**:Teleflex**Expected Travel**: None**Requisition ID**: 10328**About Teleflex Incorporated****Global Operations -** Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.**Position Summary****Principal Responsibilities**- 1. Develop comprehensive project plans outlining re-validation objectives, timelines, resource requirements, and risk management strategies.- 2. Coordinate with internal stakeholders, including manufacturing, quality assurance, regulatory affairs, and engineering teams, to define project scope and deliverables.- 3. Execute project plans, monitor progress, and proactively identify and address any issues or deviations from established goals.- 4. Ensure all re-validation activities comply with relevant regulatory standards, including FDA regulations (e.g., 21 CFR Part 820) and international quality standards (e.g., ISO 13485).- 5. Maintain a thorough understanding of regulatory requirements related to process re-validation in the medical device industry and integrate them into project planning and execution.- 6. Foster effective communication and collaboration among cross-functional teams involved in re-validation projects.- 7. Facilitate regular project meetings, provide updates on project status, and solicit input from team members to drive project success.- 8. Act as a liaison between internal stakeholders and external partners/vendors as needed to support project objectives.- 9. Ensure accurate and comprehensive documentation of all re-validation activities, including protocols, reports, and other relevant documentation.- 10. Identify opportunities for process improvements and efficiencies in re-validation procedures, documentation practices, and project management methodologies.- 11. Implement best practices and lessons learned from previous re-validation projects to enhance future project outcomes.**Education / Experience Requirements**- Qualification:- Bachelor's degree in engineering, life sciences, or related field.- Experience:- Proven experience (7-10 years) in project management within the medical device or pharmaceutical industry, with a focus on process validation or re-validation.**Specialized Skills / Other Requirements**- Other Competencies/Skills:- Strong understanding of regulatory requirements and quality standards to medical device manufacturing (e.g., FDA QSR, ISO 13485)s- Excellent communication, leadership, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.Productivity and Problem-Solving Technique.- PMP certification or equivalent project management credentials preferred- Ability to work well in a team environment and collaborate across departments- Proactive to learn and highly organized with a keen attention to detail and the ability to prioritize and manage multiple projects simultaneously**Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.****Teleflex is an equal opportunities employer**- Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries._
