Quality Operations Supervisor

Insulet; Gelang Patah; On-site; MYR 100,000 - 150,000; Full time

Job summary

A medical device company in Gelang Patah is looking for a Quality Operations Supervisor to lead quality teams, manage inspection and testing processes, and ensure adherence to ISO13485 standards. The ideal candidate should have a Bachelor's degree in engineering or science and experience in quality operations within the medical device industry. Proficiency in English and Malay is essential, along with strong analytical skills and attention to detail. This role offers a chance to contribute to meaningful projects in a dynamic environment.

Qualifications

• 2-3 years of hands-on experience in quality operations, especially in medical devices.
• Understanding of ISO13485 requirements is an advantage.
• Proficient in English and Malay, with good documentation practices.

Responsibilities

• Lead and train Quality Team Leads and Inspectors.
• Manage IPQA activities and oversee investigations.
• Support Quality and lot release teams with MES/SAP issues.

Skills

Quality operations

Inspection and testing

Microsoft Excel

Attention to detail

Effective communication

Education

Bachelor's degree in engineering or science

Job description

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!

Job Title: Quality Operations Supervisor

Department: Quality

Manager/Supervisor: Manager, Quality Operations

Job Grade: 6

Position Overview

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.