Engineer III, QA

Thermo Fisher Scientific - Haverhill, MA

Full-time - Entry Level

Haverhill, MA

Computer and Electronic Product Manufacturing

About the position

The position involves supporting the Supplier Quality Management (SQM) team in onboarding new suppliers and materials, ensuring compliance with quality standards, and maintaining accurate documentation. The role requires collaboration with suppliers and internal teams to manage quality assurance processes and documentation effectively.

Responsibilities

• Support SQM team and core SQM processes with onboarding of new suppliers and materials
• Assign, track and reconcile GMP documentation
• Support Quality activities for key processes including Vendor/Supplier Change Notifications (VCN/SCNs) and Supplier Corrective Action Requests (SCARs)
• Establish and implement Quality Technical Agreements with suppliers
• Construct internal and external audits as well as regulatory inspections
• Support supplier status changes to ensure that the Approved Supplier (Vendor) List is accurate and complete
• Maintain filing system for the supplier quality documentation

Requirements

• Master's degree or foreign degree equivalent in Mechanical Engineering, Industrial Engineering, or a related field of study plus 0 years of experience
• Bachelor's degree or foreign degree equivalent in Mechanical Engineering, Industrial Engineering, or a related field of study plus 2 years of manufacturing quality assurance experience or related experience as an equivalent alternative
• Knowledge or experience with GMP Regulations
• Knowledge or experience with Quality Assurance
• Knowledge or experience with Change Controls
• Knowledge or experience with QMS Auditing
• Knowledge or experience with CAPA
• Knowledge or experience with Quality System regulations
• Knowledge or experience with Supplier and Material Risk estimation
• Proficiency in Microsoft Office (MS Excel, MS Word, MS PowerPoint)
• Proficiency in Adobe Software Suites (Adobe Acrobat, Adobe Sign)
• Experience with Smartsheet WorkApps
• Experience in leading cross-functional meetings
• Experience in triaging Supplier/Vendor Notifications
• Experience in data analysis
• Experience in technical writing