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Staff QC Engineer/Scientist

Location
Carlsbad, CA

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Job Description
Job Title
: Staff QC Engineer/Scientist
Requisition ID:
75520BR


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.

Responsibilities:
Create and implement Quality Management System (QMS) processes.
Conduct QMS training.
Conduct Quality Management System gap analysis.
Ensure quality documents are aligned to ISO regulations and QMS.
Create and implement projects for product quality improvement.
Investigate root cause analysis, analyze and correct non conformances (internal, external and systemic issues).
Participate in Corrective Action and Preventive Action (CAPA).
Review and evaluate product/process trends, participating in process and product improvement plans, as needed.
Ensure risk management deliverables are completed for all the processes/products (i.e., dFMEA, pFMEA).
Lead risk assessment activities (initial risk assessment and any process change risk mitigation plan).
Responsible for review and approval of installation qualifications (IQs) engineering studies, operation qualification (OQs) and process performance qualification (PPQs), as needed.
Create quality documents, revise quality documentation. Recommend revision of specifications whenever needed.
Conduct internal audits.
Participate in third-party audits (Regulatory, ISO, etc.)
Participates actively in cost reduction and continuous improvement projects.
Participate in change control activities for
Minimum Qualifications
7 years of experience in a Quality Assurance/ Quality Engineering position.
BS in industrial, quality, chemical or mechanical engineering or demonstrate equivalent work experience in the Quality Engineering area or Bachelors in Scientific Discipline or related field.
Knowledge in standards and regulations such as ISO 13485:2016 Medical Devices – Quality Management System and ISO 14971:2012 Medical Devices – Risk Management, ISO 9001:2015 cGMP.
Preferred Qualifications:
Familiarity with enterprise software systems including Agile, TrackWise®, SAP-LMS.
Strong ability to manage personnel, projects and work requirements.
Knowledgeable in motivating and positively influencing peers.
Ability to read, analyze, and interpret common scientific and technical data, QMS standards, and safety documents.
Ability to effectively present information to groups of employees, site leadership, and customers.
Ability to define problems collect data, establish facts, and draw valid conclusions
This position is not approved for relocation assistance
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
Apply today ****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.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process,
click here
for further assistance.
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.

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