Quality Operations Engineer – QC & Compliance

Insulet Corporation; Selangor; On-site; MYR 67,000 - 100,000; Full time

Job summary

Insulet Corporation in Malaysia seeks an Associate Engineer, Quality Operations. You will support validation, testing, and reporting of in-process, pre- and post-sterile release and environmental monitoring samples, ensuring activities are efficient and compliant with cGMP.

Responsibilities include lot qualification testing, in-process QA testing, QA equipment validation, CAPA and deviation handling, trend analysis, and supporting internal and external audits.

Qualifications

• Bachelor's degree in science or engineering required.
• Fresh grad or have experience in quality in the medical device industry.
• Microbiology testing experience will be an advantage.
• Fluent in English and Malay language.
• Auditor training certification to ISO13485 or other industry QMS standard preferred.
• Ability to prioritize multiple competing deliverables simultaneously.

Responsibilities

• Ensure the completion of lot qualification testing of production release to maintain customer supply.
• Manage in-process quality assurance testing, environmental monitoring and microbiology testing.
• Take part in QA equipment validation activities, set up inspection procedures based on specifications and qualify testing system.
• Handling quality issues, perform and involve in failure investigation, NCMR, deviation, CAPA, and field return etc. within the Master Control system.
• Review and update Quality documentation (Quality Control Plan, Manufacturing Instruction & Others) as necessary.
• Track, trend and analyze lot qualification test data and provide routine feedback to Manufacturing, Quality, and Lifecycle Engineering.
• Optimize the pre and post sterilization product testing process as appropriate.
• Drive continuous improvement into the investigational process to yield more efficient and robust processes.
• Enhance quality system processes as it pertains to management of assigned deliverables to ensure compliance.
• Conduct trainings and certification assessments for lot qualification inspectors.
• Develop and/or manage quality programs related to resolution of issues arising from manufacturing operations as well as post manufacturing activities.
• Provide QA Engineering support and expertise to Manufacturing, Engineering, Marketing and other company functions.

Skills

Communication

Interpersonal skills

Multilevel collaboration

Education

Bachelor's degree in science or engineering

Tools

Word

Excel

Outlook

Job description

Insulet Corporation in Malaysia seeks an Associate Engineer, Quality Operations. You will support validation, testing, and reporting of in-process, pre- and post-sterile release and environmental monitoring samples, ensuring activities are efficient and compliant with cGMP.

Responsibilities include lot qualification testing, in-process QA testing, QA equipment validation, CAPA and deviation handling, trend analysis, and supporting internal and external audits.