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:                             Principal Business Analyst, Quality

Department:                     Quality Operations

Manager/Supervisor:    Program Director, Quality System

FLSA Status:                       

Responsibilities:

Reporting to the Program Director, Global Quality Systems, the Quality System Principal Business Analyst will lead and support the SAP Master data governance process under Quality systems and support Quality Operations for SAP updates to standard business functions. The Principal Business Analyst will partner with Quality function to support SAP continuous improvement of the system in partnership with IT and quality business users.
 

• Maintain the SAP master data records that represent the Arena ECO/PO/TCO processes.
• Led the SAP master data owners through the Master Data governance process, by notifying MD owners that change is required.
• The role is accountable that master data owners have executed all changes into SAP to support the approved Arena ECO/PCO/TCO documents.
• The roles work closely with IT to ensure that the interface between Arena and SAP is working as expected.
• This role is the key person to identify and prioritize quality system changes within the IT change management system.
• This role can execute of oversee all SAP system changes to support the day-to-day quality business functions such as Quality Plan updates and assignments.
• Develop industry-leading quality and business processes regarding Quality execution system using SAP.
• Integrate processes and configuration between SAP and the electronic QMS, Product Lifecycle Management (Arena)
• Partner with Operations, IT, Supply Chain, Finance, and Arena PLM Administration
• Support franchise product launches to meet timelines.
• Provide guidance and direction on procedures and requirements for meeting applicable regulations and standards.
• Provide decision and judgment on quality issues pertaining to risk acceptability.
• Ensure that all documentation regarding the Quality Management System is effectively maintained
• Perform other duties as assigned.

Preferred Skills/Competencies:

• Strong leadership and analytical skills with team-focused attitude
• Strong understanding of the SAP master data structure
• Strong understanding of Arena QMS
• Self-starter with demonstrated ability to design, develop, and automate business processes.
• Excellent interpersonal, verbal, and written communication skills
• Comfortable in a fast-paced environment with minimal direction
• Ability to organize and judge priorities
• Ability to communicate and work effectively at multiple levels within the organization
• Advanced PC skill, word processing, spreadsheet, and database skills

Requirements
 

• BS degree in scientific discipline, or equivalent

• Minimum of 10 years’ relevant experience in Quality Systems, Engineering, and/or Operations within the Medical Device industry

• Detailed knowledge of current Good Manufacturing Practices and IT system validation requirements

• Significant knowledge regarding the use of MRP with SAP

• Significant knowledge regarding the use of PLM in Medical Device

• Experience working in an electronic QMS.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid

Additional Information:

The US base salary range for this full-time position is $85,400.00 - $128,300.00. 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.