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: Manager, Quality Operations
Department: Quality
Manager/Supervisor: Senior Manager, Quality Operations
FLSA Status:
SOP Group:
Responsibilities:
Reporting directly to the Senior Manager, Quality Operations, the Manager, Quality Operations provides oversight 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. The role will have formal people management responsibilities.
- Manage various QC programs/processes within the department (training, sample management, data review and reporting) and serves as subject matter expert (SME).
- Coordinates and facilities QC activities to meet commitments on-time
- Ensure QC personnel have appropriate training.
- Leads planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification
- Assist in troubleshooting of test methods and/or equipment as required
- Authors, review, and/or approves data, SOPs, COAs, and DHRs
- Monitor, track and publish QC metrics
- Ensure all QC records and DHR documentation adhere to cGMP/GDP expectations
- Leads compliance related teams working towards the goal of continuous improvement
- May be required to lead NCMR, OOT investigations/deviations and to identify corrective actions to prevent reoccurrence
- Serves as QC representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all QC needs
- Participates in internal and external quality audits
- Recruits, coaches, and develops organizational talent
- Perform other duties as assigned
Requirements
- Bachelor's degree (preferably science or engineering discipline) required.
- At least 5 years or more in Medical Device Quality Operations with minimum 2 years in managerial level.
- Fluent in both English and Malay language.
- Ability to communicate and work effectively at multiple levels within the organization
- Must possess strong leadership and analytical skills with team-focused attitude.
- Experience in leading or supporting ISO 13485, MDSAP or FDA audits/inspections.
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
- Intermediate to advanced skill level of MS Word, Excel, Access, Auto Cad or equivalent.
Top Skills
What We Do
Insulet Corporation, 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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. 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. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
