Thermo Fisher Scientific Staff Quality Engineer, APQP in Asheville, North Carolina
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 $17 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.
How You Will Make a Difference:
This position is the lead role for the Advanced Product Quality Planning function and a strategic partner with new and existing Product Development Engineering teams located at multiple domestic and international sites that are internal and external to the company. May require requires occasional travel to these locations. It’s a critical liaison to success of new product launches and changes to existing products which requires building strong relationships. It will require utilizing expertise and solid working knowledge of Quality and Manufacturing processes to engage and effectively influence Engineering and Management Levels internal and external to the Company. The position develops new product quality control plans across multiple product lines while providing direction and consult for implementation of quality process control plans to Product Design Engineers, Process Design Engineers, Quality Engineers and Supplier Engineers. Work as core team member on New Product Development teams to take projects from Concept to full production and implement necessary controls to ensure successful launch and manufacturing execution.
What You Will Get to Do:
• Develops, implements, and maintains new Advanced Product Quality Planning (APQP) processes and revises existing APQP Plans across multiple product lines incorporating benchmark and standardized processes across the Company while ensuring flawless product quality measures are instituted.
• Is the Lead Quality Expert as member of New Product Development Team(s) to assure development and execution of Quality Plans as critical subset of Product Development Plans
• Trains and Coaches others in APQP techniques and in the use of scientific approaches including statistical tools
• Audits APQP plans for compliance
• Travels as need to NPD team meetings and to support Supplier Engineers, Supplier Development Activities and to help develop and oversee their implementation of effective corrective action plans
• Other miscellaneous assignments including traditional Quality Engineer duties
• MS preferred - BS degree required
• Program Manager experience preferred
• Extensive senior level quality engineering experience using quality systems and tools involving supplier relations and new product development
• Advanced knowledge of quality continual process improvement techniques in a Lean manufacturing environment and in statistical waste reduction techniques
• Proficient in process auditing with significant competency in analyzing. troubleshooting and resolving complex quality situations.
• Solid Technical Experience in driving quality improvement in international supply chain
• Knowledgeable in advanced data collection, measuring, analysis, improvement and control
• Strong knowledge of manufacturing processes (assembly, weld, metal forming, paint, electrical assembly) and quality control methodologies and documentation
• Working experience with the FDA Quality System Regulation (21CFR820), ISO 9000, ISO 13485 quality standards
• Experience in medical device industry and products a plus
• A minimum of two commercially successful new product deployments required
• Advanced Level Quality Systems experience required
• Manufacturing or biomedical assessment activities strongly preferred
• Verbal and written communication skills including good persuasion skills required
• ASQ Quality Engineer Certification desirable
• Prior new product deployment quality planning / program management with commercialization success
• Excellent verbal and written communications skills in international environment
• Passion for math, scientific method and statistical thinking
• Strong Quality Systems understanding
• Strong statistical methodologies background (SPC, Statistical Problem Solving)
• Typical sheet metal and electro-mechanical assembly manufacturing environments. Working environment requires safety shoes and glasses.
Responsibility for Others:
• No direct reports. However, will coach and direct others in APQP techniques and deployment of individual Quality Plans.
• Travel on occasion may be frequent in support of assigned projects and supplier development. Normal office environment with significant time spent on the manufacturing floor.
Relocation Assistance approved for this role.
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.
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.