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.

Supplier Quality Specialist (Hybrid)

About the job

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!

This Supplier Quality Specialist is responsible for ensuring supplier governance and governance of related quality systems.  The Specialist creates, monitors, and reports on metrics that show the health and capability of the supplier quality system.  The individual maintains records and databases needed for those metrics.  The Specialist ensures current products and new projects meet the regulatory and quality requirements for medical devices.  The Specialist interfaces with other Insulet departments (e.g. Sr. Management, Operations, Information Technology, Engineering, Purchasing, New Business Development and Regulatory Affairs) as well as suppliers, contractors, and other external parties on issues related to supplier quality, quality management systems, materials, product support and external and internal audit support.  Effectively communicating quality system metrics, status, and requirements are critical to the success of the position. 

Responsibilities
 

• Develop and monitor key performance indicators and other metrics.
• Develop and deploy dashboards and other visualizations needed to support metrics.
• Provide stewardship of records related to Supplier Quality in a PLM database.
• Create and update supplier quality systems and related quality system documents (e.g., work instructions for generating and monitoring metrics, corrective and preventive action, part approval, and work instruction documents).
• Develop and deploy training for these documents.
• Ensure company compliance with these policies, procedures, and work instructions.
• Support resolution of issues with quality nonconformances in supplied parts, services and internal processes.
• Support Audit, Root Cause Analysis, and Corrective and Preventive Action activities.
• Review, provide input, and approve new product documentation, as required.
• Review and approve Material and Component documents and protocols.
• Support Risk Management activities and ensure compliance with standards and regulations.
• Performs other duties as assigned.
   

Education And Experience

Minimum Requirements:
 

• BS degree in a data science, engineering, scientific, computer systems, or quality management curriculum or equivalent experience.
• A minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
• Experience in the development and implementation of effective Supplier Quality Metrics and Controls.
• Experience in data analysis.
• Experience in Quality System Audits.
• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices.
• Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).  Fluent in visualization software (e.g., Power BI).
• Demonstrated experience organizing and maintaining large documentation sets.
• Ability to follow up with task owners to close out open items.
• Familiarity with structured phase-gate product development processes.
• Familiarity with FDA, ISO, and other international regulatory requirements.
   

Preferred Skills and Competencies
 

• Effective verbal and written communication skills.
• Experience collaborating and communicating with individuals at multiple levels and roles in an organization.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Skilled in software including word processing, spreadsheet, database applications, visualization / business analytics applications, PLM and ERP software.
• Working knowledge of ISO 62304, Medical Device Software – Software Life Cycle Process
• Able to work effectively in a high-stress, high-energy environment.
   

Physical Requirements
 

• Travel as required to support business needs
   

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 $69,500.00 - $104,450.00. 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.