Job title: Quality Engineer
Requisition ID: 51977BR
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.
Position Summary: Support key product lines to enable and facilitate the improvement of quality of services and products provided by the Marietta Manufacturing Center of Excellence. Drive shift of quality responsibility to the process owners. Enhance Customer Allegiance and drive down Cost of Quality in complete value chain from supplier to end user of products and services. Steward and teach scientific approaches including, statistical techniques and Practical Process Improvement methodologies in a “Lean” environment. Measure and report operational performance on Key Business Metrics for assigned suppliers, and products. Travel as necessary, worldwide, to facilitate product transfers, perform root cause analysis, and conduct process audits and to enable Continual Improvement.
- Enable collaborative relationships with customers, suppliers and internal departments to prevent quality related wastes.
- Deliver product metrics, trends and graphs in support of site goals.
- Drive plant wide corrective and preventive action activities (using 8D, A3, and similar methodologies) with special emphasis on evaluation of returned customer product and leading corrective action teams to determine solutions to permanently eliminate root cause.
- Lead a Customer Focused Improvement Team (CFIT)
- Teach Process Improvement Tools and routinely coach use of tools.
- Drive supplier quality improvement and measure effectiveness.
- Capture internal and external quality performance data and provide linkage to process owners to drive improvement.
- Conduct formal assessments of internal and external processes.
- Provide a continual flow of recommendations to reduce systemic waste.
- Serve as a manufacturing liaison during new product development.
- Engage in harmonizing, maintaining and enhancing the Asheville’s and Marietta’s Quality Management System.
- May serve as back up for complaints and recall process.
- Demonstrate continual self-improvement.
- Perform all job duties in a safe manner and obey all safety policies and procedures.
- Perform all job duties consistent with the Code of Ethics and the 4-I Values.
- Perform all job duties within ISO standards, regulatory or statutory requirements.
- Perform other duties as assigned.
- Bachelor’s degree from an accredited higher learning institution.
- Proficient at extracting data using Excel tools, pivot tables, filters etc.
- 5 years’ experience in Quality Systems is required;
- Background in statistical process control.
- Strong verbal and written communication skills including good persuasion skills are a must.
- ASQ, Quality Engineer Certificate or commitment to obtain ASQ, Certified Quality Engineer Certification, within 24 months of hire is required.
- Domestic and International travel up to 10% is required.
- Thorough working knowledge of various continual process improvement techniques and CAPA. Proficient in process auditing and statistical waste reduction techniques. Knowledgeable in data collection, measuring, analysis, improvement and control. Proficient in use of Microsoft Office Suite. Working experience with Good Manufacturing Practices, FDA, ISO 9000, ISO 13485 and risk based quality standards. Working knowledge of manufacturing processes, validation and change control concepts for medical device manufacturing.
Desired Qualifications and Experience:
- Engineering degree preferred and MBA desired.
- 10 + years’ experience in Quality Systems is desired.
- 5 years’ experience in a manufacturing environment desired.
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