“What I do at Thermo Fisher Scientific extends outward-to my coworkers, to the scientific community and to people around the world who benefit from our innovative thinking and advanced technology.”
-Thermo Fisher Scientific, Employee
Job Title: QA Manager
Requisition ID: 51974BR
When you’re part of the team at Thermo Fisher, 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.
- Create and implement the 3-5 year quality strategy for the Petaluma site that supports growth and compliance readiness.
- Act as the Management Representative with third party agencies, regulatory agencies and any government agency for the site.
- Provide leadership to the quality function necessary to ensure that strategic and annual quality planning is integrated into strategic and operating plans with broad-based organizational involvement.
- Manages the QC lab, factory quality and the QA teams (4-6 direct reports; 20 indirect)
- Implement and maintain systems to ensure the measurement of progress towards key quality goals and objectives.
- Maintains and develops the quality system to fulfill global quality system requirements (e.g. ISO 9001 and 13485).
- Assure management reviews of the Quality System are held and properly documented to reflect the status of the Quality System effectiveness and resulting corrective actions and improvement plans/actions. Works closely with all staff to ensure that all aspects of the QMS is understood, implemented and maintained.
- Influence all business functions to apply appropriate quality tools including Lean, Six Sigma, TQM principles, business process improvement methods and statistical methods (e.g. design of experiments, statistical process control)
- Develops and implements Quality Agreements with key customers.
- Maintains alliance with local and corporate Quality and Regulatory Affairs to ensure participation in and understanding of associated initiatives.
- Participates in New Product Development Process. Assures new product quality requirements are met before product launch.
- Manages Corrective and Preventive Action System. Works with various departments to identify actions required to assure corrective and preventative actions are properly documented and follows up to initiate and monitor timely completion of actions.
- Oversees the Internal Audit program assuring compliance with applicable standards. Leads any external or customer audits.
- Participates with Human Resources to assure training is available to all employees regarding the Quality System and the Quality Policy.
- Manages Key Quality Business Metrics and Department Metrics.
- Participates actively in quality improvement projects to move the organization from QC to QA. Carries out leadership responsibilities in accordance with the organization’s policies and applicable laws.
- Other duties may be assigned, as required.
- 5+years Quality Manager experience preferably in an IVDD, ISO 9001 and/or ISO 13485 certified medical-device manufacturing company.
- Experience managing employee performance (including coaching & feedback).
- 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.
- This position requires a Bachelor’s Degree or equivalent in engineering (other science disciplines may be considered) and a minimum of five (5) years of relevant work experience in a low to medium complex manufacturing environment.
- MS Office (Word, Excel, Access and PowerPoint) intermediate level. Understanding of Statistical software and/or databases.
- Able to use statistical software such as Minitab or equivalent.
- Descriptive and inferential statistics knowledge ASQ Quality Engineer or Quality Manager Certified
- ASQ lead auditor training Experience with any of the following would be considered a plus: FDA regulations, Taguchi or DOE methodologies.
- 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, quality system standards, 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.
- Travel approximately 10% to work with different sites on Continuous Improvement initiatives.
At Thermo Fisher Scientific, each one of our 50,000 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