Quality Engineer II

Location
Pleasanton, CA
Salary
Competitive
Posted
September 28 2017
Ref
55517BR
Position Type
Full Time
Job Description

Job Title: Engineer II, QA
Requisition ID: 55517BR


When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals

Responsibilities:




    Actively partner with Manufacturing departments to provide Quality Assurance support for material non-conformances, deviation management and complaint investigationsLead root cause analysis, implement/provide corrective actions and ensure their effectivenessCreate, maintain and evaluate product/process trends, designing and/or participating in process and product improvement plansRecommend product revisions, process changes, and testing procedures to assure that quality standards are being attainedCreate quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product qualityConducts and reports internal audits to promote improvement and compliance with the site's Quality Management System requirements and national/international standards and regulations Participate actively in Continuous Improvement programsParticipate in change control activities for documents and manufacturing processesReview/approve IQ/OQ/PQ and risk analyses when designatedCollect, analyze, and present Quality dataOther duties may be assigned, as required


Minimum Qualifications:



    2+ year experience in a Quality Assurance position, ideally in a manufacturing environmentExperience with application of standards such as ISO 13485 and ISO 9001 to operations processesBS in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or demonstrated equivalent work experience in the Quality Engineering area pertaining to a scientific industry


Preferred Qualifications:


    Understanding of IVD (21 CFR 809) and Quality System Regulations (QSR) for Medical Devices (21 CFR 820), and ISO 14971:2007 Medical Devices - Risk ManagementKnowledge of Operations and manufacturing processesScientific laboratory experienceFamiliarity with enterprise software systems including Agile, TrackWise®, SAP


At Thermo Fisher Scientific, each one of our 55,000 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.


*IND-LSG




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.