Quality Operations Engineer (Supervisor)

Insulet Corporation; Johor Bahru; On-site; MYR 90,000 - 130,000; Full time

Benefits offered by this job

Competitive Package and Benefits

Career Growth and Development Opportun

Exciting Opportunities to join US Med

Job summary

Insulet Corporation is the global leader in tubeless insulin pump technology with its Omnipod brand of products. We develop, manufacture, and sell our proprietary Omnipod continuous insulin delivery systems for people with diabetes.

The role supports QC, validation, testing, and environmental monitoring in a fast-paced manufacturing environment. The Quality Operations Supervisor role reports to the Manager, Quality Operations and focuses on ensuring cGMP compliance, effective data analysis, and

Qualifications

• Bachelor's degree in science or engineering.
• 2–4 years quality experience in the medical device industry.
• Fluent in English and Malay.
• ISO13485 knowledge and quality systems.
• Auditor training certification to ISO13485 preferred.
• Proficient in MS Word, Excel, Outlook and PowerPoint.
• Ability to prioritize multiple deliverables.

Responsibilities

• Ensure adoption, compliance and control of analytical functions in QC supporting validation, testing and release.
• Manage in-process QA testing, environmental monitoring and microbiology testing.
• Lead CAPA, NCMR, deviations and field returns within Master Control system.
• Review and update Quality documentation (QCP, Manufacturing Instructions, etc.).
• Generate weekly, monthly and quarterly data analysis reports for management.
• Support product release initiatives and participate in audits.

Skills

Multilevel communication

Interpersonal skills

English & Malay fluency

Problem solving

Communication skills

Education

Bachelor's degree in science or engineering

Tools

Word

Excel

Outlook

PowerPoint

Job description

Quality Operations Engineer (Supervisor)

Reporting directly to the Manager, Quality Operations, the Engineer, Quality Operations is responsible to ensure adoption, compliance and control of a variety of analytical functions that occur in the QC department supporting validation, testing, reporting of in-process, pre and post sterile release, and environmental monitoring samples. This role also ensures activities occur in an efficient and cGMP compliant manner.

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, performing and involve in failure investigation,NCMR, deviation, CAPA, and field return 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 (functional, packaging, etc.) 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, as it relates to Manufacturing Quality.

Generate weekly, monthly and quarterly data analysis reports for management visibility.

Assist or leads CAPA evaluation and closure as related to operations quality processes.

Support product release initiatives and tasks as needed.

Participating in external and internal audits.

Performs other duties as required.

Requirements

Bachelor's degree (preferably science or engineering discipline) required.

2 to 4 years of experience in quality in the medical device industry is an added advantage

Fluent in both English and Malay language.

Ability to communicate and work effectively at multiple levels within the organization.

Good interpersonal skills in dealing with peers and other functional areas.

Working knowledge of ISO13485 quality system standard.

Auditor training certification to ISO13485 or other industry QMS standard preferred.

The ability to prioritize multiple competing deliverables simultaneously.

Must be proficient in Word, Excel, Outlook and Power Point.

Manufacturing 1,001-5,000 employees

Insulet Corporation is the global leader in tubeless insulin pump technology with its Omnipod® brand of products. We develop, manufacture, and sell our proprietary Omnipod continuous insulin delivery systems for people with insulin-dependent type 1 and type 2 diabetes. Founded in 2000. Global HQ in Acton, Massachusetts. Offices in every corner of the world — US, UK, France, Germany, Netherlands, Canada, China, Malaysia, Mexico, Australia, and U.A.E. We sell our products in 25 different countries.

Insulet Corporation is the global leader in tubeless insulin pump technology with its Omnipod® brand of products. We develop, manufacture, and sell our proprietary Omnipod continuous insulin delivery systems for people with insulin-dependent type 1 and type 2 diabetes. Founded in 2000. Global HQ in Acton, Massachusetts. Offices in every corner of the world — US, UK, France, Germany, Netherlands, Canada, China, Malaysia, Mexico, Australia, and U.A.E. We sell our products in 25 different countries.

• Competitive Package and Benefits
• Career Growth and Development Opportunities
• Exciting Opportunities to join US Medical Device