Document Controller Coordinator

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

Job summary

A leading medical device company in Gelang Patah, Malaysia, is seeking a Document Controller Coordinator to oversee Quality Operations. Responsibilities include executing lot release, maintaining inspection records, and ensuring compliance with documentation standards. Candidates must have a Diploma in Engineering or Science and at least 3 years of experience in quality operations within the medical device sector. Proficiency in English and Malay is essential, along with strong communication and analytical skills.

Qualifications

• Minimum Diploma in Engineering or Science, or relevant combination of education and experience.
• At least 3 years of hands-on experience in quality operation, inspection and testing, preferably in the medical device industry.
• Proficient in both English and Malay languages.

Responsibilities

• Responsible for executing lot release of finished products.
• Review completed DHR for completeness and accuracy.
• Maintain inspection records and data entry in systems.

Skills

Effective written and verbal communication skills

Data entry

Analytical skills

Team player

Organizational skills

Education

Diploma in Engineering or Science

Tools

Microsoft Excel

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: Document Controller Coordinator

Department: Quality

Manager/Supervisor: Senior Engineer, Quality Operations

Job Grade: 3

Position Overview:

The Document Controller Coordinator, Quality Operations is responsible for all aspects of Quality Operations Device History Record (DHR) and Quality Records administration. All work to be done in accordance with complying Insulet’s defined Standard Operating Procedures, Work Instructions and Health & Safety requirements at all times.

Responsibilities:

• Responsible for executing lot release of finished product, including review and completing record / checklist required for lot release.
• Take lead in ensuring effective movement of DHR file through Production and Quality to ensure a timely delivery of completed accurate file for the Medical Device DHR.
• Review completed DHR for completeness, accuracy and GDP.
• Maintain inspection records and ensure data entered the computer and/or MES/SAP system.
• Responsible for the identification, storage, security and integrity, retrieval, retention, and disposition of the DHR records and retained samples.
• Assist in activities that contribute to upholding high standards of DHR and Quality Records.
• Responsible for improving and providing effective review of the documentation review process.
• Support in Quality Operations related administrative activities as required.
• Provide training as necessary to fulfill the responsibilities of the role.
• Participate in continuous improvement into the investigational process to yield more efficient and robust processes.
• Preparing daily, weekly and monthly reports of lot release & quality inspection testing.
• Assist Quality Engineers in handling CAPA, NCMR and MRB.
• Participate in internal or external quality audits, as required.
• Performs other duties as required.

Requirements

• Minimum Diploma in Engineering or Science, or with a combination of education and experience.
• At least 3 years of hands‑on experience in quality operation, inspection and testing, preferably in the medical device industry.
• Reasonable understanding of ISO13485, GMP and GDP requirements.
• Experience in GDP (Good Documentation Practices) & legible handwriting.
• 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.

Skills/Competencies:

• Effective written and verbal communication skills.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Team player and ability to communicate effectively to all levels and functions.