Quality Engineer

Boston Scientific; Penang; On-site; MYR 70,000 - 90,000; Full time

Job summary

A global medical device company is seeking a Quality Engineer in Penang, Malaysia, to develop and maintain quality engineering methodologies that meet regulatory requirements. Responsibilities include implementing process control systems, ensuring compliance with quality standards, and leading quality initiatives. Ideal candidates should hold a Bachelor's degree in Engineering or Science with at least 5 years of experience in a Quality environment, preferably in medical devices. Proficiency in Bahasa Malaysia and English is required.

Qualifications

• Minimum 5 years of working experience in a Quality environment.
• Conversant with validation techniques and associated regulatory requirements.
• Experience from a medical device background is a plus.

Responsibilities

• Identify and implement effective process control systems for product manufacturing.
• Ensure quality methodologies meet BSC, customer, and regulatory requirements.
• Develop testing methodologies and documentation for products.

Skills

Project management

Validation

Problem solving

Communication

People management

Education

Bachelor's degree in Engineering, Science, or related field

Job description

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

Responsibilities

• Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Ensure Quality engineering methodologies, systems, and practices meet BSC, customer, and regulatory requirements.
• Create and revise departmental procedures.
• Act 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.
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• For those individuals that supervise others: assure that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.
• For those individuals that supervise others: establish and promote a work environment that supports the Quality Policy and Quality System.

Requirements

• Bachelor's degree in Engineering, Science, or a related field.
• At least 5 years of working experience in a Quality environment.
• Required skills: project management, validation, problem solving, communication, people management.
• Required languages: Bahasa Malaysia, English.
• Candidate from a medical device background is an added advantage.
• Candidate involved in project transfer / product transfer is an added advantage.