DC Quality Engineer (Junior)

Boston Scientific; George Town; On-site; MYR 60,000 - 100,000; Full time

Job summary

A leading company in the medical technology sector is seeking a Quality Engineer to enhance quality initiatives and ensure compliance with regulatory standards. The position requires a Bachelor's degree and relevant experience in Quality Engineering, with a focus on innovation and quality systems compliance. The successful candidate will work onsite in Penang, contributing to the advancement of life-changing medical solutions.

Qualifications

• 3-7 years in Quality Engineering or related fields from MNC.
• Experience in project management is an advantage.
• Background in medical devices preferred.

Responsibilities

• Implement process control systems for product development and manufacturing.
• Develop testing and inspection methodologies for new and existing products.
• Ensure compliance with quality policies and regulatory requirements.

Skills

Process Control Systems

Problem-Solving

Leadership

Communication

Education

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

Job description

Purpose Statement

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.

Job Responsibility

• 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.
• In all actions, demonstrates 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, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.
  

Job Requirements

• Candidate required process at least bachelor's degree in any Engineering, Science or related field.
• At least 3-7 years working experience in Quality Engineering/ Quality Control/ Quality Operations from MNC.
• Positive attitude and has winning spirit/ dare to try behavior
• Has potential to be leader – Good communicator, good articulator
• Candidate from medical device background will be added advantage.
• Candidate involve in project management skills / project transfer will be added advantage.
• Willing travel to Batu Kawan, Penang.
• Work mode: Onsite.
  
  

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.