About Thermo Fisher Scientific:
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and 55,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
- Manages program for periodic evaluation of internal suppliers – drives appropriate classification of suppliers, and collects relevant information to support evaluation decisions. Coordinates quality agreements with internal sites.
- Reviews requests for change notification agreements from external customers; ensures executed agreements are entered into appropriate systems. Reviews engineering change requests/orders to determine if customer notification is required.
- Administers logistics for Engineering Change Control process – tracks progress of active change requests, maintains Validation Review Board meeting schedule and records, works with manufacturing and engineering teams to ensure required deliverables are submitted for review.
- Works closely with Document Control Analyst to implement and coordinate periodic document review process
- Provides responses to information requests (e.g. quality questionnaires) from other company locations and external customers
- Performs daily complaint review and reporting in coordination with department Complaint manager
- Generates and distributes metrics and reports to support Quality Assurance objectives
- Other responsibilities as assigned
- 5 years+ experience in Quality Assurance/Quality Systems, ideally in a biotechnology or medical device setting.
- Bachelor’s degree in biology, chemistry or related field
- Good working knowledge of FDA, GMP, ISO 13485, and ISO 9001 regulations.
- Proficiency with Microsoft Word, Excel, Powerpoint. Experience with Agile, SAP and TrackWise is highly desirable.
- Strong oral and written communication skills, attention to detail, with a demonstrated ability to work in a cross-functional team environment
- Ability to manage competing priorities and acknowledge a sense of urgency