Quality Technician

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 45,000 - 78,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. seeks a QA professional to perform routine final functional testing, product/material release criteria testing/inspection, and accurate recording of results in line with QA lab and plant procedures.

The role includes reviewing QA documentation, initiating and closing nonconforming reports, and supporting Monthly Nonconformance Board discussions while ensuring timely closes and high internal customer service levels.

Qualifications

• Candidate must possess at least a Diploma / Degree in Engineering, Science or equivalent.
• Experience with QA release processes and nonconformance handling is expected.
• Familiarity with SAP and quality notification workflows is preferred.

Responsibilities

• Routine final functional testing, product/material release criteria testing/inspection and recording of test results.
• Review and update of QA Documentation.
• Initiate and work on nonconforming report. Ensure the nonconforming report is closed in timely manner.
• To provide assistance and support to the Quality Engineering and Operations function.
• Compliance to all QA Laboratory and all relevant plant wide procedures and practices.
• Compliance to all standard and regulation.
• Provision of excellent service to all internal customers.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
• Decision making ability coupled with the ability to work on ones own initiative and with minimum supervision is required.
• Good interpersonal skills and organizational skills.
• Excellent attention to detail.
• Identifies, resolves and prevents Manufacturing issues by determining root cause and implementing corrective and preventive action.

Skills

Distribution Centre QA Release Process

SAP System

Quality Notification

Product Nonconformance Handling

Education

Diploma / Degree in Engineering, Science or equivalent

Job description

Routine final functional testing, product/ material release criteria testing/inspection and recording of test results. Review and update of QA Documentation. Initiate and work on nonconforming report. Ensure the nonconforming report is closed in timely manner. Assist in compiling Monthly Nonconformance Board Report on an ad hoc basis.

Job Responsibilities

Routine final functional testing, product/material release criteria testing/inspection and recording of test results.

Review and update of QA Documentation.

Initiate and work on nonconforming report. Ensure the nonconforming report is closed in timely manner.

To provide assistance and support to the Quality Engineering and Operations function.

Compliance to all QA Laboratory and all relevant plant wide procedures and practices.

Compliance to all standard and regulation.

Provision of excellent service to all internal customers.

Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.

Decision making ability coupled with the ability to work on ones own initiative and with minimum supervision is required.

Good interpersonal skills and organizational skills.

Excellent attention to detail.

Identifies, resolves and prevents Manufacturing issues by determining root cause and implementing corrective and preventive action.

Job Requirements

Candidate must possess at least a Diploma / Degreen in Engineering, Science or equivalent.

Required skill(s): Distribution Centre QA Release Process, SAP System, Quality Notification, Product Nonconformance Handling

Required language(s): Bahasa Malaysia, English

At least 1-3 year(s) of working experience in the related field is required for this position.

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 our 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 our 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.