Associate Engineer, Quality Operations

Insulet Corporation; Malaysia; On-site; MYR 60,000 - 100,000; Full time

Job summary

Insulet Corporation in Malaysia seeks an Associate Engineer, Quality Operations to ensure analytical QC functions align with validated processes and cGMP standards. The role supports validation, testing, and reporting across sterile release and environmental monitoring, driving efficient quality outcomes.

Responsibilities include lot qualification, QA testing, CAPA, deviation handling, and documentation updates, with emphasis on process improvement and cross-functional collaboration in a

Qualifications

• Bachelor's degree in science or engineering required.
• Fresh graduate or quality experience in medical devices is acceptable.
• Familiarity with ISO13485 and quality systems preferred.

Responsibilities

• Ensure adoption, compliance and control of analytical functions in QC for validation, testing and reporting of in-process, pre and post-sterile release and environmental monitoring.
• Maintain efficient, cGMP-compliant operations and support quality program activities.
• Complete lot qualification testing to support production release and supply.
• Manage in-process QA testing, environmental monitoring and microbiology testing.
• participate in QA equipment validation activities and set up inspection procedures.
• Handle quality issues, investigation, NCMR, deviation, CAPA and field return within Master Control.
• Review/update Quality documentation (QCP, Manufacturing Instructions) as necessary.
• Track, trend and analyze data and provide routine feedback to Manufacturing, Quality, and Lifecycle Engineering.

Skills

English

Malay

Interpersonal

Communication

Auditor training

ISO13485

Education

Bachelor's degree in science or engineering

Tools

Word

Excel

Outlook

PowerPoint

Job description

Job Summary Responsibilities: Reporting to the Manager, Quality Operations, the Associate 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. Responsibilities: Reporting to the Manager, Quality Operations, the Associate 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, 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 (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. Support site during external audits (i.e., BSI, FDA, customer). Performs other duties as required.

Requirements Bachelor's Degree (preferably science or engineering discipline) required. Fresh grad or have experience in quality in the medical device industry. Microbiology testing experience will be an 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.

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! Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights) Insulet employees are all focused on the same goal to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.