Insulet Corporation

Insulet Corporation

Sr. Supplier Quality Engineer (Onsite - Acton, MA)

Acton, Massachusetts, USA · Senior

Sponsorship not specified$87k-$131kDetected 7 hours ago
Business DevelopmentAuditingSupply ChainProcurementMechanical DesignFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMentoringOrganizational SkillsInternal AuditRegulatory Affairs

About the role

  • Insulet started in 2000, driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives using our Omnipod® product platform.
  • In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
  • We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

Responsibilities

  •  Responsible for supplier quality engineering (SQE) deliverables to support Plastics category sourcing strategies and continuity of production.
  •  Experience in plastic injection molding. Knowledge in mold tool design, material selection, design for manufacturability (DFM), cosmetic criteria definition, and process qualification.
  •  Develop and monitor key performance indicators (KPIs) and other metrics.
  •  Lead SQE efforts in sustaining projects to accomplish primary objectives, including cost reduction, capacity increase, dual sourcing, and risk mitigation.
  •  Engage partnerships with suppliers (including sub-tiers) and supply chain management (SCM) to drive superior supplier performance and accountability.
  •  Lead root cause analysis of supplier-related non-conforming product issues to address and resolve quality concerns via Supplier Corrective Action Report (SCAR).
  • Drive corrective action and supplier improvement activities that directly impact performance for assigned suppliers.
  • With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle.
  • Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller.
  • 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.

Requirements

  •  Develop and deploy dashboards and other visualizations required to support metrics.
  •  Experience with supplier quality system (QMS), process, and for-cause audits.
  • Performs other duties as required.

Nice to have

  • BS degree in engineering, a technical or scientific discipline
  • Master's degree in engineering or technical or scientific discipline preferred.
  • 5-7 years' experience in the FDA regulated environment.
  • Experience in Quality in an FDA regulated industry.
  • Experience with QSR Part 820, ISO 13485 and ISO 14971.
  • Experience with ETO sterilization methods preferred.
  • Experience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments).
  • Experience with word processing, spreadsheet, database programs.

Skills

  • Effective verbal and written communication skills.
  • Effective collaboration and communication with individuals at multiple levels in an organization.
  • Ability to organize and judge priorities.
  • Ability to generate and maintain accurate records.
  • Ability to follow up with task owners to close out open items.
  • Strong problem solving / root cause analysis skills.
  • Good verbal (including presentation) and written communication skills, especially technical report writing.

Compensation

  • Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $87,300.00 - $130,950.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:

Company info

  • We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint.
  • We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations.
  • We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
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