- Prepare and execute all documentations as per QMS & Change Management process such as CRF, PVP, IQ-OQ-PQ protocols, recording test results, write validation reports, submit for approvals, etc.
- Work with SQ, RA, QA and relevant global teams to gather information and approvals for projects.
- Arrange and conduct trainings after completion of projects as per Training requirements.
- Prepare and Maintain site master validation plan.
- Review validation are conducted as per protocols.
- Support Materials Initiatives Validation Team when when needed on other matters related to project planning, execution and closure.
- Scope – Covers all Procurement related projects for APAC sites
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R&D Engineer
Found in: Foundit MY A2 - 3 days ago
Teleflex Perak, Malaysia Full timeExpected Travel: None · Requisition ID: 9960 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of ident ...
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R&D Engineer
Found in: Foundit MY A2 - 2 days ago
Teleflex Perak, Malaysia Full timeExpected Travel: Up to 10% · Requisition ID: 10002 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of ...
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Civil & Structure Engineer
Found in: Foundit MY A2 - 5 hours ago
Johan Jurutera Perunding Perak, Malaysia, Ipoh Full timeJob Responsibility · Develop, prepare and/or review engineering plans and designs for civil works, structures, facilities, and/or systems. · Develop, prepare and review reports and studies to identify and recommend engineering solutions. · To provide and produce all civil design ...
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Found in: Foundit MY A2 - 5 hours ago
Wolfspeed Perak, Malaysia, Ipoh Full timePartner with cross functional team to identify and drive improvements in manufacturability, yield, performance, quality and reliability for our power products. · Lead or assist in setting up equipment, production lines and processes & implement process changes and equipment modif ...
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Validation Engineer
Found in: Foundit MY A2 - 2 days ago
Teleflex Perak, Malaysia Full timeExpected Travel: None · Requisition ID: 9939 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of ident ...
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R&D Assistant Manager
Found in: Foundit MY A2 - 5 hours ago
Teleflex Perak, Malaysia Full timeExpected Travel: None · Requisition ID: 10224 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of iden ...
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Assistant Manager, Global Packaging
Found in: Foundit MY A2 - 2 days ago
Teleflex Perak, Malaysia Full timeExpected Travel: Up to 25% · Requisition ID: 10027 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of ...
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IT Manufacturing Solution Architect
Found in: Foundit MY A2 - 5 hours ago
Wolfspeed Perak, Malaysia, Ipoh Full timeUnderstand Semiconductor device manufacturing dicing/ saw and probe flows. · Be the MES subject matter expert, understand the best practices and standards. · Understand the business, requirements, processes for the area of scope and to become SME for design, change and improvemen ...
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Product Support Engineer
Found in: Foundit MY A2 - 1 day ago
Valorx Perak, Malaysia, Ipoh Full timeWe are looking for motivated individuals with customer-facing support experience and an insatiable curiosity for technology. In concert with Pre-Sales, Customer Success, and Product Teams, Product Support Engineers play a critical role in making customers successful. Valorx Produ ...
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Senior MOL Process Engineer
Found in: Foundit MY A2 - 6 days ago
Coherent Malaysia Sdn Bhd Perak, Ipoh, Malaysia Full timeRESPONSIBILITIES Responsible for the process yield and establish and implement corrective actions to improve yield. · Pan and execute process improvement projects in line with business metrics. · Responsible to define KPIV, conduct gage R&R studies, correlation studies & implem ...
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Regulatory Affairs, Team Lead
Found in: Foundit MY A2 - 5 hours ago
Teleflex Perak, Malaysia Full timeExpected Travel: None · Requisition ID: 10250 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of iden ...
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Supplier Quality Engineer
Found in: Talent MY C2 - 1 day ago
wolfspeed Ipoh, Malaysia Full timeJob Summary · Wolfspeed Semiconductor Quality division is seeking a proven, hands-on Outgoing Quality Engineer based in Malaysia. This position reports to Wolfspeed Supplier Quality Engineering Manager for Global Operations. The Outgoing Quality Engineer will play a key role to ...
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Quantity Surveying/ Civil Engineering
Found in: Talent MY C2 - 1 day ago
Kuala Lumpur Kepong Berhad Ipoh, Malaysia InternshipSHIPQuantity Surveying/civil engineering (Internship) Based in: Head Office, Ipoh Responsibilities Preparing tender documents (BQ), contract documents, payment cert, procurement, logistic, administration works. · To read technical drawings. · Updating price rates. · Any other jobs as ...
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Process Development Team Lead
Found in: Talent MY C2 - 1 day ago
wolfspeed Ipoh, Malaysia Full timeLead a team of process development engineers in development activities to support the OPM product and package development needs from ground zero to safe launch. · Provide innovative ideas and solution to support cost , yield , product performance improvement. · Establish Design ...
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Electrical & Instrumentation (Internship)
Found in: Talent MY C2 - 1 day ago
Kuala Lumpur Kepong Berhad Ipoh, Malaysia InternshipSHIPELECTRICAL & INSTRUMENTATION (Internship) Based in: Head Office, Ipoh Responsibilities Major electrical & instrumentation standard documents update · Prepare new electrical standard documents · Prepare electrical design, drawing (AutoCAD) & calculation · Mill visit for taking ele ...
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Staff Assembly Manufacturing Engineer
Found in: Talent MY C2 - 1 day ago
wolfspeed Ipoh, Malaysia Full timePartner with cross functional team to identify and drive improvements in manufacturability, yield, performance, quality and reliability for our power products. · Lead or assist in setting up equipment, production lines and processes & implement process changes and equipment modi ...
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Manufacturing Engineer
Found in: Talent MY C2 - 1 day ago
wolfspeed Ipoh, Malaysia Full timePartner with cross functional team to identify and drive improvements in manufacturability, yield, performance, quality and reliability for our power products. · Lead or assist in setting up equipment, production lines and processes & implement process changes and equipment modi ...
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Senior Staff Test/ Wafer Probe Manufacturing Engineer
Found in: Talent MY C2 - 1 day ago
wolfspeed Ipoh, Malaysia Full timePartner with cross functional team to identify and drive improvements in manufacturability, yield, performance, quality and reliability for our power products. · Lead or assist in setting up equipment, production lines and processes & implement process changes and equipment modi ...
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Regulatory affairs manager
Found in: beBee S2 MY - 1 day ago
Factory & Marketing Office Kl-kepong Rubber Products Sdn Bhd Ipoh, Malaysia Full timeResponsibilities: To manage medical device registration, 510(k) listing, medical device licensing and permit. To manage product testing and certification in compliance with regulatory requirements. To liaise with medical device authorities, representatives, and certification bodi ...
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Assistant Project Manager
Found in: Manatal GBL S2 T2 - 9 hours ago
Hunters International Sdn Bhd Ipoh, MalaysiaAbout the Client · Established in Perak since 1974, our client is an Electrical & Air Conditioning Specialist. · Responsibilities · 1. Project Planning and Scheduling: · Develop project plans, schedules, and budgets. · Coordinate with clients, engineers, architects, and other s ...
Validation Documentation Engineer - Perak, Malaysia - Teleflex
Description
Expected Travel: NoneRequisition ID: 9937
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit
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
Education / Experience Requirements
Degree in Engineering, Science or Math,
Experience
: Experience in ISO13485, FDA Audit, Process Validations, Change Management.
: 3-5 years experience in validation activities
: Experience in IQ,OQ and PQ testing requirements
: Some knowledge about Regulatory Authority requirements
: Knowledge on MDD and MDR
: Has worked on Master Validation Plan
: Has experience in conducting training on validation and quality related matters
: COF & CRF issuance
Specialized Skills / Other Requirements
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.
Validation Documentation Engineer professionals in Ipoh
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VISHNU RAM MUTHIAH
CIVIL ENGINEER
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kosalai armugam
EHS ADMIN