Senior Quality Systems Specialist

Thermo Fisher Scientific - San Jose, CA (30+ days ago)3.6

Job Description
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 $22 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.

How Will You Make an Impact?
Responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485 and ISO9001. Specifically, functions including record management and document control.

What will you do?
Co-ordinate the management of site records in compliance with applicable regulations and standards.
Generate standard operating procedures to define and improve quality system functions.
Support the eDMS electronic documentation process as needed.
Participate in interdepartmental initiatives for continuous improvement.
Facilitate process improvement within other department, through the use of training, coaching, and team participation.
Support the corrective action program, with hands on ownership for investigation and resolution of issues.
Participate in the internal auditor program
Participate in any other quality management system tasks, as directed by the manager

How will you get there?
Bachelor's degree in scientific, quality system, or related discipline, with practical experience in a regulated manufacturing environment or equivalent experience
A minimum of 4-6 years of relevant experience.
Excellent verbal and written communication skills in group or one-on-one settings.
Computer skills, e.g., word, excel, access, Microsoft project, electronic documentation systems, ERP systems.
Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
Experience in compiling data to support metrics analyzing current process.
Ability to work in an office environment

At Thermo Fisher Scientific, each one of our 70,000 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.

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.