Quality Engineer

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 120,000 - 180,000; Full time

Job summary

Boston Scientific in Penang, Malaysia, seeks a Quality representative to develop and maintain quality engineering methodologies, systems and practices aligning with BSC, customer and regulatory requirements. You will support NPD, operations or system/services teams and drive quality initiatives across the site.

Responsibilities include implementing process controls for development and manufacturing, creating procedures, and leading quality decision-making.

Qualifications

• Must have at least a Bachelor's degree in Engineering, Science or related field.
• At least 5 years of experience in Quality environment.
• Strong skills in project management, validation, problem solving, communication, and people management.

Responsibilities

• Identify and implement effective process control systems for development and manufacturing of products.
• Ensure quality engineering methodologies and practices meet customer and regulatory requirements.
• Create and revise departmental procedures.
• Lead or contribute as a team member to quality disciplines and decisions.
• Apply systematic problem-solving to identify, prioritize, and resolve quality issues.
• Develop and execute testing and inspection methodologies and documentation for new/existing products.
• Review and develop validation protocols and reports; support validation activities.
• Interface with other engineering departments, customers and suppliers on quality issues.
• Demonstrate commitment to patient safety and product quality per Quality Policy.

Skills

Project management

Validation

Problem solving

Communication

People management

Education

Bachelor's degree in Engineering/Science

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.

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

EnsureQuality 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 must possess at least bachelor's degree in any Engineering, Science or related field.

At least 5 years of working experience in Quality environment.

Required skill(s): project management, validation, problem solving, communication, people management

Required language(s): Bahasa Malaysia, English

Candidate from medical device background will be added advantage.

Candidate involved in project transfer / product transfer will be added advantage.

Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding your footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Our work is guided by core values that define Boston Scientific culture and empower our employees.

Boston Scientific by the numbers:

45K employees worldwide

33M patients treated each year

16,000+ products that change lives

$12.682 billion sales in 2022

130 countries with commercial representation

- from Boston Scientific Performance Report 2022.

Expanding your footprint in APAC

In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.