Engineer III, QA

at  Thermo Fisher Scientific

REQUIREMENTS:

Master’s degree or foreign degree equivalent in Mechanical Engineering, Industrial Engineering, or a related field of study plus 0 years of experience. Employer will also accept a 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:
1. GMP Regulations;
2. Quality Assurance;
3. Change Controls;
4. QMS Auditing;

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; and
Maintain filing system for the supplier quality documentation.
TRAVEL: Up to 10% domestic travel required.