Quality Operation Supervisor

Insulet Corporation; Gelang Patah; On-site; MYR 70,000 - 110,000; Full time

Job summary

Insulet Corporation in Malaysia seeks a Quality Supervisor to lead Quality Team Leads and Inspectors, aligning cross‑functional teams to meet departmental goals and company objectives.

The role drives IPQA activities, oversees lot release, and supports MES/SAP processes while mentoring the QA team to uphold ISO13485 and GDP requirements.

Qualifications

• Bachelor’s degree in engineering or science.
• Experience in quality operation, inspection and testing (2–3 years) in the medical device industry.
• Knowledge of ISO13485 is an advantage.
• Experience with GDP and legible handwriting.
• Knowledge of GLP is a plus.
• Proficiency in Excel, data entry and analytical skills.
• Proficient in English and Malay.
• Strong communication and attention to detail.

Responsibilities

• Provides leadership to team members, including training on processes and procedures.
• Manages IPQA activities and oversees nonconformances investigations to release lots on time.
• Manages pre- and post-sterile Lot Qual lab and oversees lot failure investigations for timely release.
• Oversees IPQA and Lot Qualification staffing for effective operations.
• Manages MES/SAP Lot release and ensures quality records are adequate.
• Supports MES/SAP issues and coordinates with materials team for corrections.
• Provides support for PQ builds and new projects.
• Collaborates with Quality Engineers to develop test methods and resolve nonconformances.
• Manages non-conforming materials from quarantine to disposition.
• Assists root-cause investigations and failure analysis.
• Reviews DHR documentation and deviations.
• Supports continuous improvement projects.
• Monitors calibration activities and test equipment investigations.
• Manages PDM quality operations and lot release to the PDM team.
• Approves/signs-off work of Quality Inspectors and supports audits.

Skills

Communication skills

Attention to detail

Analytical skills

Team player

Education

Bachelor's degree

Tools

Microsoft Excel

Job description

Job Summary

The Supervisor plays an integral part of Insulet’s Quality Department as the leader of Quality Team Leads and Quality Inspectors, 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.

Position Overview

The Supervisor plays an integral part of Insulet’s Quality Department as the leader of Quality Team Leads and Quality Inspectors, 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.

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!