Supplier Quality Enginee

Duration 6 months 
Location Latham NY
 

Summary Description: 

The Supplier Quality Engineer (SQE) will serve the Diagnostic Imaging global supply chain management to drive quality activities with suppliers, setting a high standard and fast response expectation so quality issues are prevented or minimized. Lead with best practices to enable our organization to provide high quality medical products to our customers. The role will manage activities downstream related to purchased part qualification with suppliers, supplier quality issue resolution and ensuring appropriate incoming material inspection strategies. 

Key Areas of Responsibility:  

• Independently Produces and completes Supplier Quality Engineering related activities and documentation. 
• Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met. 
• Qualifies and sustains sub-processes of suppliers, including performing process validations for critical supplier processes impacting part quality. 
• Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results. 

SQE: 
• Part Qualification for Product Lifecycle Maintenance 
o Partner with Design Engineer and to determine Part Qualification requirements 
o Partner with Supplier and Design Engineering to complete the qualification of materials 
o Partner with supplier to plan special process validation activity, where required 
o Complete Part Qualification / Special Process validation activities 
o Support the Creation of and Maintenance of Receiving and Inspection Plans 
o Manage Supplier Change Request and Advanced Deviation Requests 

Minimum Qualifications 
• Master’s or Bachelor’s Degree in math, statistics or engineering with 5+ years of industry experience 
• Required 3+ years Supply Chain Management Engineering experience 
• Preferred experience in Quality Tools and Processes (e.g., GD&T, APQP, DFMEA, PFMEA, PPAP, VOC, SPC, 8D, 6σ, etc.) 
• Knowledge and experience in IVD, Pharmaceutical, and or Medical Device Industry; Industry Standards for Validation; Industrial Statistics, Federal cGMPs & QSRs, ISO 13485, Risk Management regulations and application (ISO14971) 

Desired Qualifications: 
• Preferred Six Sigma Certification 
• Preferred ASQ Certified Quality Engineer 
• Experience in project management 
• Working knowledge of production and process controls 
• Strong technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation) 
• Strong analytical aptitude (i.e. statistical techniques, database development) 
• Experience with development and implementation of quality system procedures 

Capabilities: 
• Ability to work independently to ensure business is able to achieve their goals 
• Demonstrated ability to develop and participate in process implementation and improvement in a team environment 
• Ability to interface with leadership and internal and external customers, responding in a professional manner 
• Ability to communicate effectively (both written and oral) using English (or local language). 
• Ability to influence team members to affect positive change 
• Conflict-resolution skills

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