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.

Job Title:                        Manager, Quality Operations

Department:                 Quality

Manager/Supervisor:   Senior Manager, Quality Operations

FLSA Status:                    

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.