Senior Receiving Technician (Quality)

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 48,000 - 72,000; Full time

Job summary

Boston Scientific Medical Device Malaysia Sdn. Bhd. seeks an experienced QA Inspector to independently audit materials and work, document non-conformances, and ensure compliance with GMP/ISO requirements. You will monitor audit metrics, assist in CAPA processes, and train junior staff.

The role covers finish goods inspection, releases, NSWR evaluations, and environmental health considerations, with a focus on accuracy and timely reporting in English across the IQA lab.

Qualifications

• Candidate must possess at least a Diploma / Degree in Engineering, Science or equivalent.
• At least 5 year(s) of working experience in the related field is required for this position.
• Required skill(s): Measurement, inspection, and ability to read engineering drawings/diagrams/prints. Strong problem-solving and root cause analysis skills.
• Required knowledge: GMP, ISO 13485 requirements, FDA Quality System Regulation (21 CFR Part 820), GDP, Nonconformance and CAPA processes, and sampling plans with AQL methodologies.
• Required language(s): Bahasa Malaysia, English

Responsibilities

• Audits materials or the work of others through examination, inspection, measurement, or test of raw materials, components, sub-assemblies, final assemblies and documentation.
• Documents the non-conformance or suspected non-conformance to standards through identification of unsuccessful audits, completion of required paperwork, system transactions, and affixing marks.
• Handle discrepant materials per documented disposition and document activities in systems or paperwork.
• Communicates the status of audit metrics and other assignments, responsibilities, and duties verbally and through periodic reports.
• Performs simple statistical analysis through data collection and input into software applications or manual calculations.
• Issues, stores, count and maintains inventory into storage areas. Handles hazardous waste; perform environmental monitoring as applicable.
• Reads and follows basic job instructions and protocols; written in English.
• Validation execution and report writing.
• Perform the finish Goods inspection and Active releases.
• Responsible for PSRR and E-releases process.
• Trains new/entry level QA Auditors on-the-job and in group or one-on-one settings.
• Compliance to QA Laboratory procedures and GMP/ISO requirements.
• Provision of excellent service to internal customers for the IQA laboratory area.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Provide training and technical guidance to laboratory staff including training records review.
• Provides an independent evaluation of material for NSWR when required.
• Perform additional duties as directed by Supervisor/Manager.
• Review and update QA Documentation.

Skills

Measurement

Inspection

Reading engineering drawings

Root cause analysis

Independent work

Statistical analysis

Education

Diploma or Degree in Engineering or Science

Job description

Purpose Statement:
The technician provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation is documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the work, or material meets Guidant's quality system requirements. The Technicians Review and update of QA Documentation. Controlling closed Exception Reports/Non-Conformances Reports. Compiling Non-Conformance Board Reports monthly & various documents for Management on an ad hoc basis.

Job Responsibilities:

Audits materials or the work of others through the examination, inspection, measurement, or test of raw materials, components, sub-assemblies, final assemblies and documentation.

Documents the non-conformance or suspected non-conformance to standards (i.e. manufacturing documentation, material/ component specifications, operating procedures, and domestic/ international standards) through the identification of unsuccessful audits, the completion of required paperwork, system transactions, and affixing his or her mark (i.e. stamp, sign-off or signature).

Handle discrepant materials per the documented disposition and document activities in the appropriate systems or paperwork.

Communicates the status of audit metrics and other assignments, responsibilities, and duties verbally and through the completion and publishing of periodic reports.

Performs simple statistical analysis through the collection and input of data into software applications or manual calculations

Issues, stores, count and maintains inventory into the different storage areas. Handles, disposes, transfer and document appropriately hazardous waste. Perform environmental monitoring (Puerto Rico).

Reads, comprehends and follows basic job instructions and/or protocols including verbal, written, diagramed, colored, etc. and other work-related documents; written in English.

Performs simple statistical analysis through the collection and input of data into software applications or manual calculations.

Validation execution and report writing.

Perform the finish Goods inspection and Active releases.

Responsible for PSRR and E-releases process.

Trains new, entry level, and less experienced Quality Auditors through on-the-job training, group training, and one-on-one guidance.

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

Compliance to all ISO9001 and current GMP procedures and practices.

Provision of excellent service to all internal customers for the IQA laboratory area.

Creation of purchase requisitions for laboratory equipment and consumables.

Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.

Provides an independent, unbiased evaluation of material for the Non-Standard Work Order (NSWR), whenever required.

Issues, stores, count and maintains inventory into the different storage areas. Handles, disposes, transfer and document appropriately hazardous waste.

Perform and assist with additional duties as may be directed by the Supervisor /Manager.

Review and update of QA Documentation.

Job Requirements:

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

At least 5 year(s) of working experience in the related field is required for this position.

Required skill(s): Measurement, inspection, and ability to read engineering drawings/diagrams/prints. Strong problem-solving and root cause analysis skills. Ability to work independently with minimal supervision. Acts as a subject matter expert for incoming inspection processes.

Required knowledge: Understanding of GMP (Good Manufacturing Practices), ISO 13485 requirements, FDA Quality System Regulation (21 CFR Part 820, as applicable), Good Documentation Practices (GDP), Nonconformance and CAPA processes, and sampling plans with AQL methodologies.

Required language(s): Bahasa Malaysia, English

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.