Sr. Supplier Quality Engineer, Onsite, Acton, MA

The Sr. Supplier Quality Engineer is responsible for ensuring current products provided by raw material / service suppliers meet the regulatory and quality requirements for medical devices.  This position interfaces with other Insulet departments (e.g. Operations, Information Technology, Engineering, New Business Development, Procurement, and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. In this role you will effectively communicate with suppliers, optimizing development, review and / or approval of tool qualification, non-conformance and other QMS documents and ensure ambiguities and conflicting requirements are resolved.

Responsibilities 

• Collaborate with external suppliers, and internal teams (Supplier Development, Project Management, Regulatory Affairs, Supply Chain, Procurement, Sustaining Engineering) to ensure raw material meets Insulet specification.

• Ensure changes to design, inspection methods, visual aids are communicated to supplier while complying to internal procedures. 

• Create and update supplier quality system and related quality system documents. 

• Review and approve Quality Management System documents and protocols. 

• Ensure company compliance with these policies, procedures, and work instructions. 

• Track trends in department and supplier performance via scorecards (e.g., CAPA completion, audit completion, certifications maintained, FMEAs and quality agreements) and report as needed. 

• Support remediation activities as needed. 

• Maintain supplier quality records in ERP and PLM databases. 

• Support resolution of issues with nonconformances in supplied parts and services. 

• Support internal and external quality system audits and related RCA, CAPA, and implementation. 

• Review and approve new product documentation, as required. 

• Review and approve Material and Component documents and protocols. 

• Support Risk Management activities and ensure compliance to standards and regulations. 

Qualifications 

• BS degree, in an engineering / scientific / computer system / or quality management curriculum or equivalent experience. 

• A minimum of 5 - 8 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and / or equivalent combination of education and experience. 

• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices Quality management systems, and ISO 14971 Medical devices. 

• Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g., Word, Excel, Access, PowerPoint). 

• Familiarity with FDA, ISO, and other international regulatory requirements. 

Preferred Skills and Competencies  

• Experience working with injection molding, stamp metal, electronics and / or EO Sterilization suppliers.

• Able to work effectively in a high-stress, high-energy environment. 

• Working knowledge of EN 60601, Safety requirements for medical electrical systems. 

• Working knowledge of ISO 62304, Medical Device Software Life Cycle Process. 

• Effective verbal and written communication skills. 

• Experience collaborating and communicating with individuals at multiple levels in an organization. 

Physical Requirements