What are the responsibilities and job description for the Operations Quality Technician (Onsite) position at Insulet Corporation?
Job Title: Technician, Quality Operations
Department: Quality
Manager/Supervisor: Engineer, Quality Operations
Position Overview
The Technician, Quality Operations is responsible for performing QA Acceptance activities in supporting testing, reporting of in-process, pre and post sterile release, environmental monitoring samples and assisting the Engineer, Quality Operations.
Responsibilities
Additional Information
The US base salary range for this full-time position is $21.00 - $31.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
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!
At Insulet Corporation 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)
Department: Quality
Manager/Supervisor: Engineer, Quality Operations
Position Overview
The Technician, Quality Operations is responsible for performing QA Acceptance activities in supporting testing, reporting of in-process, pre and post sterile release, environmental monitoring samples and assisting the Engineer, Quality Operations.
Responsibilities
- Perform lot qualification testing of production release to maintain customer supply.
- Conduct in-process quality assurance testing, environmental monitoring and microbiology testing.
- Perform first level troubleshooting of product inspection/testing issues and escalate issues when necessary.
- Maintain inspection records and ensure data entered the computer and/or MES/SAP system.
- Assist Quality Engineer to optimize the pre and post sterilization product testing process as appropriate.
- Track and trend qualification test data (functional, packaging, etc.) and provide routine feedback to Quality Engineer.
- Participate in continuous improvement into the investigational process to yield more efficient and robust processes.
- Conduct training on usage of tester equipment and assist Quality Engineer on certification assessments for lot qualification inspectors.
- Assist Quality Engineers in handling CAPA, NCMR and MRB.
- Participate in internal or external quality audits, as required.
- Performs other duties as required.
- 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. Microbiology testing experience will be an advantage.
- Experience in test method validation and GR&R will be an advantage.
- Reasonable understanding of ISO13485 requirements.
- Experience in GDP (Good Documentation Practices) & legible handwriting
- Knowledge of GLP (Good Lab Practices) will be a plus.
- 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.
Additional Information
The US base salary range for this full-time position is $21.00 - $31.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
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!
At Insulet Corporation 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)
Salary : $21 - $32
