DC Quality Engineer (Junior)

Boston Scientific Gruppe; Penang; On-site; MYR 100,000 - 150,000; Full time

Job summary

A global leader in medical technology is seeking a Quality Engineer in Penang. This role involves implementing quality engineering methodologies and ensuring regulatory compliance, providing support for new product development and operational processes. Ideal candidates will possess a Bachelor's degree and relevant experience in quality engineering within the medical devices sector. Join us to make a significant impact on patient safety and product quality at a recognized company.

Qualifications

• 3-7 years working experience in Quality Engineering, Quality Control, Quality Operations.
• Candidate from a medical device background is an advantage.
• Positive attitude and strong communication skills.

Responsibilities

• Identify and implement effective process control systems.
• Develop testing and inspection methodologies.
• Interfacing with engineering departments on quality issues.

Skills

Process control systems

Problem-solving

Communication

Project management

Education

Bachelor's degree in Engineering, Science or related field

Job description

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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.

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.

Job Segment: Medical Device Engineer, Quality Engineer, Compliance, Manufacturing Engineer, Medical Device, Engineering, Legal, Healthcare