Quality Operations Supervisor

Insulet; Gelang Patah; On-site; MYR 70,000 - 100,000; Full time

Job summary

Insulet Malaysia seeks a Quality Supervisor to lead the Quality Team Leads and Inspectors, ensuring GMP compliance and timely lot releases. You will manage IPQA activities, investigations into nonconformances, and collaborate with MES/SAP, Materials, and QA Engineers to drive continuous improvement.

Strong attention to detail and cross-functional communication are essential. Minimum bachelor’s in engineering or science and 2–3 years in quality operations, preferably in the medical device

Qualifications

• Bachelor’s degree in engineering or science.
• 2–3 years of hands-on experience in quality operation, inspection and testing, preferably in the medical device industry.
• ISO13485 knowledge is an advantage.
• GDP & legible handwriting.
• GLP knowledge is a plus.
• Proficient in English and Malay.
• Strong communication and teamwork.
• Detail-oriented and efficient.

Responsibilities

• Provide leadership to Quality Team Leads and Inspectors.
• Manage IPQA activities and nonconformance investigations.
• Oversee lot release and calibration activities.
• Collaborate with MES/SAP and Materials teams for corrections.
• Support PQ builds and new projects.
• Develop test methods with QA Engineers to ensure proper inspection.
• Review DHRs, nonconformances and deviations.
• Participate in continuous improvement projects.
• Approve/sign-off on quality inspections.

Skills

Team leadership

Quality management

Attention to detail

Cross functional teamwork

Education

Bachelor's degree in Engineering or Science

Tools

MES

SAP

Job description

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The Supervisor plays an integral part of Insulet’s Quality Department as the leader of Quality Team Leads and Quality Inspector, must be quickly adaptive to changing priorities The role requires strong organization skills and attention to detail while working in cross functional teams to accomplish departmental and company goals.

Responsibilities:

Provides leadership to team members, including but not limited to, training support on processes and procedures.

Responsible for managing the IPQA activities and overseeing all nonconformances investigation and provide the support needed to release lot on time.

Responsible for managing the pre- and post-sterile Lot Qual lab and overseeing all lot failure investigation and provide the support needed to release lot on time.

Oversee IPQA and Lot Qualification personnel to ensure adequate staffing levels are maintained for effective operations support.

Manage MES/SAP Lot release to ensure that quality record is created and adequate for all products.

Support Quality and lot release team with any MES/SAP issue and work with the materials team to perform the necessary corrections as soon as the issue is identified.

Provide support for all PQ builds and all new projects request.

Works with Quality Engineers, and other team members, in development of test methods to ensure effective inspection and test procedures are implemented and maintained with resolution of nonconformances, and investigations.

Manage the process for handling non-conforming materials, from quarantine to disposition.

Assists Quality Engineers in root-cause investigations for quality issues and failure analysis.

Reviews applicable DHR documentation including inspection records, nonconformances, and deviations.

Manages, facilitates, and participates in continuous improvement projects.

Monitor calibration activities and investigation of test equipment

Manage PDM quality operation to ensure that all quality inspection and lot release are provided to the PDM operation team.

Approves / signs-off work of Quality Inspectors and support quality audits, as required

Requirements

Minimum bachelor’s degree such as engineering or Science.

At least 2-3 years of hands-on experience in quality operation, inspection and testing, preferably in the medical device industry.

Reasonable understanding of ISO13485 requirements is added advantage

Experience in GDP (Good Documentation Practices) & legible handwriting

Knowledge of GLP (Good Lab Practices) will be a plus.

Microsoft Excel, data entry and analytical skills.

Must be proficient in both English and Malay language.

Team player and ability to communicate effectively with supervisor and other employees.

Must demonstrate great attention to detail and have ability to work efficiently.