Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 employees globally. 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, deliver medicines to market and increase laboratory productivity.
Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
Monitors and coordinates programs in order to sustain and improve quality systems, reduce waste, and increase quality of products and processes, consistent with established industry standards and corporate objectives by performing the following duties personally or through subordinates.
- Coordinates Petaluma plant activities related to the customer complaints.
- Coordinates customer-complaint related CAPA (Corrective Action and Preventive Action) program at the Petaluma plant. Works with various departments to identify the root cause of problems, define the necessary actions required to assure corrective and preventative actions are properly implemented and documented. Perform the task of verification of effectiveness of the CAPAs.
- Administers Quality database programs as part of our quality system.
- Administers Key Business Metrics and Department Metrics. Works with management and department managers to identify and monitor metrics associated with the various departments
- Communicate with customers to address the quality issues in a timely and the most effective way.
- Perform inspection of parts or other necessary tests if needed.
- Participate in the process and product improvement plans.
- Participates actively to cost reduction and PPI programs
- Other duties may be assigned, as required.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- One year of experience in an ISO 9001 and/or ISO 13485 certified medical-device manufacturing company.
- Hands-on experience in managing CAPA system.
- Strong computer skills including data based programs such as excel and access.
- Experience with FMEA and other preventive-action tools
- Experience with problem-solving techniques such as Fishbone diagram and 8D.
- BS preferable in Mechanical or Industrial Engineering
- MS Office (Word, Excel, Access and PowerPoint) intermediate level.
- Statistical software and/or databases.
- Experience will Lean or Six Sigma programs
- Able to use statistical software such as Minitab or equivalent.
- Ability to write technical reports.
- 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 journals, financial reports, and safety documents.
- Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
- Ability to effectively present information to groups of employees, other managers and customers.
- Ability to define problems collects data, establish facts, and draw valid conclusions.
Apply today! http://jobs.thermofisher.com