Regulatory Affairs jobs in Malaysia

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Works closely with R&D and Manufacturing in the development of robust, capable, cost effective & safe manufacturing processes. equipment, materials and products and supports efficient and effective transfer of new products & processes into commercial production.

Job Responsibilities:

Demonstrates strong technical expertise on process/product technologies to support selection, design, optimization, validation and troubleshooting of, and can mentor engineers and technicians in problem resolution on, those technologies.

Liaises with Equipment Engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.

Demonstrates strong knowledge of DFSS/DMAIC tools and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.

Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment. and summarises, analyses and draws conclusions from test results leading to effective technical resolution.

Co-ordinates the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.

Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.

Demonstrates strong knowledge and application of Process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.

Completes or leads the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.

Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.

Supervision of one or more Technicians, managing their technical development and facilitating their daily and project tasks.

Demonstrates a primary commitment to patient safety and product quality.

Ensuresall direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Understands and complies with all the regulations governing the quality systems.

Job Requirements:

Candidate required to process at least Bachelor's in engineering or any related field.

At least has 5-7 years working experience at process / process development.

Skill:Process development, new product introduction, process improvement, statistical analysis.

Has medical background will be added value.

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

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