Engineer III, QA

Thermo Fisher Scientific - Haverhill, MA

Full-time

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 as required 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
• Required knowledge or experience with GMP Regulations
• Quality Assurance
• Change Controls
• QMS Auditing
• CAPA
• Quality System regulations
• Supplier and Material Risk estimation
• Microsoft Office (MS Excel, MS Word, MS PowerPoint)
• Adobe Software Suites (Adobe Acrobat, Adobe Sign)
• Smartsheet WorkApps
• Leading Cross-functional meetings
• Triage of Supplier/Vendor Notifications
• Data Analysis
• Technical Writing