Job Title: Staff QA Engineer/Scientist
Requisition ID- 124785BR- Staff QA Engineer/Scientist
 
When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of more than $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location/Division Specific Information
US – California - Pleasanton / GSD
How will you make an impact?
The role of the Staff QA Engineer/Scientist is to support, strengthen and advance the Quality mission, which is enabling our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services. The Staff QA Engineer/Scientist will work with various team members and internal and external customers, with a high degree of professionalism. This is a very hands-on role and works collaboratively with other departments on projects including new products and the transfer or improvement of existing products.
What will you do?
 

• QA Representative who leads and participates in cross-functional and multi-site team projects (e.g. NPI, new products transfers) ensuring that project deliverables comply with quality standards, SOPS, and regulations
• Responsible for ensuring that design transfer activities are appropriately defined, executed and reported in support of effective transfers to manufacturing
• Both a technical and quality understanding is required to review and evaluate all related technical documentation and quality documentation for transfer of projects
• Guides development and implementation of validation plans and master validation plans
• Provides guidance in planning and execution of risk management activities and deliverables
• Guides resolution of complex and critical problems, including identification of root cause, and ensures corrective/preventive actions are identified to ensure timely resolution of such problems
• Manages or supports Engineering Change Control process by reviewing Engineering Change Requests
• Provides quality training and guidance to the organization. Mentors other Quality Assurance staff in effective support for NPI and transfer projects
• Evaluation of process and software validations
• Prepares clearly written business communications, investigation summaries, policies and procedures
• Supports projects and various stages of regulatory requirements
• Works primarily in an office environment, but also requires time in laboratory/manufacturing environments.

• Bachelor’s degree, preferably in biology, chemistry, biotechnology or related science. PhD preferred.

• Minimum 10 years related Quality Assurance experience working in ISO 9001, ISO 13485 and/or GMP environments.
• Quality experience, ideally in a biotechnology or medical device company
• Experience leading risk management, evaluating process/ QC Method/Software validations, and transferring new products to manufacturing
• Experience with IQ/OQ/PQ

• Must demonstrate sound independent judgment and the ability to apply quality standards and regulations to operational processes and activities
• Must demonstrate effective leadership in guiding project teams to adopt practices consistent with ISO 13485 and GMP requirements, as applicable
• Must demonstrate a proactive approach and take a leadership role as a Quality representative on teams
• High energy level; positive attitude; works well under stress
• Hands-on, action-oriented, and demonstrate a bias for continual improvement
• Must have effective communication skills and demonstrated ability to work collaboratively and cross-functionally
• Must demonstrate strong organizational skills and attention to detail.
• Must be able to acknowledge sense of urgency and adapt to organizational changes.
• Strong computer skills (MS Office, Visio, Project); experience with SAP, Agile, Trackwise and database systems preferred.

 
This position does not have relocation assistance
 
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com
 
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.