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
RequirementsBachelor'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.#J-18808-Ljbffr