About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 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. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific. For more information, please visitwww.thermofisher.com.
Role and Responsibilities
* Create and implement projects for product quality improvement
* Investigate, analyze and correct non conformances (internal, external and systemic issues)
* Lead root cause analysis, implement/provide corrective actions and ensure their effectiveness (internal, external and systemic issues)
* Create, maintain and evaluate product/process trends, designing and/or participating in process and product improvement plans.
* Ensure process risk assessment is complete in all the processes/products (i.e., dFMEA, pFMEA)
* Lead risk assessment completion (initial risk assessment and any process change risk mitigation plan)
* Responsible to create and maintain the master validation plan
* Responsible to approve and help develop installation qualifications (IQs) engineering studies, operation qualification (OQs) and process performance qualification (PQs) when designated
* Participate in existing and new test methods validations
* Ensure quality documents are aligned to regulations and practices
* Create quality documents, revise quality documentation. Recommend revision of specifications whenever needed
* Participate as internal auditor
* Participate in external audits
* Participates actively in cost reduction and continuous improvement projects
* Participate in change control activities for documents and manufacturing processes
* Participate in Product Development Process assuring elements are maintained and compliant with ISO 13485 and applicable regulations (i.e., traceability matrix, design verification stages, process validation, quality control plan)
* Other duties may be assigned, as requiredQualifications and Education Requirements
* 3+ years experience in a 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 13485:2003 Medical Devices Quality Management System and ISO 14971:2012 Medical Devices Risk Management, ISO 9001:2008 cGMP.
Preferred Skills
* 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 respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
* 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.
* Knowledge in standards such as ISO 13485:2003 Medical Devices Quality Management System and ISO 14971:2012 Medical Devices Risk Management, Title 21 United State Code of Federal Regulations (CFR)