Senior QA Inspector & Non-Conformance Lead

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; Sur place; MYR 48 000 - 72 000; Plein temps

Résumé du poste

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

Responsabilités

• 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.

Connaissances

Measurement

Inspection

Reading engineering drawings

Root cause analysis

Independent work

Statistical analysis

Formation

Diploma or Degree in Engineering or Science

Description du poste

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.