Quality Supervisor

Insulet Corporation; Malacca City; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical device company in Malacca is seeking a Quality Supervisor to lead Quality Assurance Technicians. This role involves managing IPQA activities, overseeing nonconformance investigations, and supporting quality audits. Candidates should have a Bachelor's degree in Engineering or Science, with 2-3 years of experience in quality operations, inspection, and testing, preferably in the medical device industry. Proficiency in English and Malay is essential, along with strong organizational and communication skills.

Qualifications

• 2-3 years of hands-on experience in quality operations, inspection and testing.
• Understanding of ISO13485 is an advantage.
• Proficient in English and Malay.

Responsibilities

• Provide leadership to Quality Assurance team members.
• Manage IPQA activities and oversee nonconformance investigations.
• Support Quality and lot release team with MES/SAP issues.

Skills

Microsoft Excel

Data entry

Analytical skills

Team player

Communication skills

Attention to detail

Education

Bachelor's degree in Engineering or Science

Job description

Position Overview

The Supervisor plays an integral part of Insulet’s Quality Department as the leader of Quality Assurance Technicians and team Leads, 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.
• Manage related IPQA and Lot Qual personnel to ensure that the right number of resources are available to maintain product 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.
• Assists Quality Engineers with equipment troubleshooting 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 Technicians 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.