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Quality RI / FG Engineer I at Boston Scientific Corporation Malaysia

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

23 Feb, 26

Salary

0.0

Posted On

25 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Process Control, Problem Solving, Validation Techniques, Data Analysis, Product Risk Assessment, Testing Methodologies, Inspection Methodologies, Documentation, Communication, Team Leadership, Regulatory Requirements, Manufacturing, Medical Device Industry, Product Transfer, Quality Operations

Industry

Medical Equipment Manufacturing

Description

Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements Ensure Quality engineering methodologies systems practices which meets BSC, customer and regulatory requirements. Create, and revise, departmental procedures. Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Develop testing and inspection methodologies and documentation for new and existing products. Generate test protocols/reports and execute qualification and validation testing. Responsible for reviewing and developing validation protocols and reports. Support other functional areas during the validation activities Interface with other engineering departments within the company, customers, and suppliers on quality related issues. Conversant with validation techniques and associated regulatory requirements Minimum Degree in Engineering or Science At least 5 years of experience in Operations Quality. Prior experience in the medical device industry is preferred. Required skills: Resolves issues using standard problem-solving tools and a strong understanding of quality operations fundamentals, including product risk assessment and data analysis to identify root causes and drive solutions. Communicates findings clearly and effectively. Process validation. Experience in product transfer will be added advantage.

Responsibilities

Identify and implement effective process control systems to support product development and manufacturing. Develop testing and inspection methodologies and documentation for new and existing products.