Supplier Quality Engineer (Onsite - Acton, MA)

Position Overview:      

Supports the selection, qualification, and management of external suppliers to lnsulet. Closely works with manufacturers and service suppliers to ensure product/service quality meets lnsulet requirements.  Interfaces with other Insulet departments (e.g. Operations, Supply Chain, and Regulatory Affairs) as well as with suppliers and other external parties on qualification efforts and issues related to product quality. Effectively communicates Quality metrics through Supplier Management Review to the organization, suppliers, and Executive Management. 

Responsibilities: 

• Maintain approved supplier list and supplier history records in accordance with quality system requirements. 

• Assist with the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications. 

• Maintains accuracy of Supplier Audit Reports and Supplier Profile 

• Plans and conducts scheduled audits of suppliers to assess compliance with lnsulet Requirements. 

• Prepares detailed trip reports and Audit Reports to document audit findings and observations 

• Communicates quality issues to suppliers as needed and aids development of corrective actions 

• Initiate and follow up on supplier corrective actions for both audit deficiencies and internal non-conformances to ensure timely closure. 

• Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility 

• Tracks and trends supplier performance, taking remedial action as needed 

• Conduct and assist with internal audits 

• Assist or leads CAPA evaluation and closure as related to the supplier quality processes and or supplier performance. 

• Participate in developmental and departmental training 

• Support Site during external audits (i.e. BSI, FDA, Customer). 

• Performs other duties as required 

Education and Experience: 

• BS/BA Degree or Equivalent 

• 2 to 4 years of experience in quality in the medical device industry 

• Medical device or related industry experience in a technical position 

• Working knowledge of the Quality System Regulation (FDA 21CFR Part 820) and ISO 13485 quality system standards 

• Auditor training certification to ISO 13485, 17025 or other industry QMS Standard  preferred 

• CQE and / or CQA certification is desirable 

Skills/Competencies: 

• Strong verbal and written communication skills, internal and external to the company. 

• Good interpersonal skills in dealing with suppliers, peers and other functional areas. 

• The ability to prioritize multiple competing deliverables simultaneously. 

• Must be proficient in Word, Excel, Outlook and Power Point. 

• Ability to lift up to 20 pounds 

Physical Requirements:  

International and Domestic travel required, up to 50%.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $68,700.00 - $103,050.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.