Job Summary

Job Title: Leader, In-Process QA Inspection

Leader, Lot Qualification Inspection

Department: Quality

Manager/Supervisor: Manager, Quality Operations

Position Overview:

The successful candidate will be responsible for leading a team of QA inspectors in managing the In-Process QA inspection and/or Lot Qualification inspection to support Insulet Malaysia manufacturing.

Responsibilities:

Manage and coach a team of QA inspectors focusing on performance, behaviors, product

quality, and inspection effectiveness.

Document and report status of In-Process QA and/or Lot Qual inspection, shifty, daily,

weekly and monthly.

Provide timely performance feedback to personnel and responsible for delivering annual

performance appraisals.

Ensure the compliance of inspection procedures and work instructions, effective inspection

and Good Lab Practices (GLP) to enhance product quality.

Ensure timely training and on-boarding of new employees.
Train and mentor QA inspectors on the QA inspection procedures and test equipment skills.
Ensures inspection output meets targeted output without compromising quality.
Perform first level troubleshooting on QA inspection issues and escalate issues when

necessary.

Support quality management processes like raising NCMR, following up CAPA, managing

Requirements:

MRB etc and other duties when required.

Minimum Diploma in a related field of study or with a combination of education and

experience.

2 - 5 years of on-the-job QA/QC inspection experience in visual inspection, precision

measurement instruments, force measurement equipment and product functional testing,

preferably in medical device industry.

Must be proficient in both English and Malay language.
Experience in a start-up production environment is a plus.
Excellent attention to detail, good organization, and capable of working independently with

minimal supervision.

Experience in GDP (Good Documentation Practices) & legible handwriting
Knowledge of GLP (Good Lab Practices) will be a plus.
Microsoft Excel and data entry skills.
Team player and ability to communicate effectively with supervisor and other employees.
Able to perform tasks with accuracy and reliability.

Job Title: Leader, In-Process QA Inspection

Leader, Lot Qualification Inspection

Department: Quality

Manager/Supervisor: Supervisor, Quality Operations

Responsibilities:

Manage and coach a team of QA inspectors focusing on performance, behaviors, product quality, and inspection effectiveness.
Document and report status of In-Process QA and/or Lot Qual inspection, shifty, daily, weekly and monthly.
Provide timely performance feedback to personnel and responsible for delivering annual performance appraisals.
Ensure the compliance of inspection procedures and work instructions, effective inspection and Good Lab Practices (GLP) to enhance product quality.
Ensure timely training and on-boarding of new employees.
Train and mentor QA inspectors on the QA inspection procedures and test equipment skills.
Ensures inspection output meets targeted output without compromising quality.
Perform first level troubleshooting on QA inspection issues and escalate issues when necessary.
Support quality management processes like raising NCMR, following up CAPA, managing MRB etc and other duties when required.

Requirements:

Minimum Diploma in a related field of study or with a combination of education and experience.
2 - 5 years of on-the-job QA/QC inspection experience in visual inspection, precision measurement instruments, force measurement equipment and product functional testing, preferably in medical device industry.
Must be proficient in both English and Malay language.
Experience in a start-up production environment is a plus.
Excellent attention to detail, good organization, and capable of working independently with minimal supervision.
Experience in GDP (Good Documentation Practices) & legible handwriting
Knowledge of GLP (Good Lab Practices) will be a plus.
Microsoft Excel and data entry skills.
Team player and ability to communicate effectively with supervisor and other employees.
Able to perform tasks with accuracy and reliability.

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!

Team Lead, IPQA