Thermo Fisher Scientific (NYSE: TMO) is headquartered in Waltham, MA, and is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual sales of more than $11 billion, we employ 38,000 people and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through three premier brands, Thermo Scientific, Fisher Scientific, and Unity Labs, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike.
This position is responsible for driving exceptional product quality, regulatory assurance and optimized Cost of Quality.
- Establishes quality benchmarks and metrics for measuring efficiencies and effectiveness of all supplier performances that affect Thermo Fisher Scientific (TFS) products and services.
- Develops initiatives and reviews metrics to identify the cost of poor supplier quality. Using various data collection methodologies, will measure, analyze and improve Supplier performance and reduce supplier non-conformances.
- Develops relationships with customers, vendors and other departments to resolve quality related issues.
- Manage FAI (First Article Inspection) Process and sure compliance to TFS requirements.
- Approve supplier selection through robust qualification processes.
- Assure supplier compliance to TFS Quality Management System & regulatory requirements through supplier monitoring process.
- Develop positive relationships and work closely with Sourcing Leaders to manage & implement supplier/engineering changes, New Product Introductions, and transfers.
- Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically Failed on Arrival/Install (FOA/FOI) issues, Field Failures, and Factory defects.
- Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.
- Aware of and comply with the TFS Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
- Complete all planned Quality & Compliance training within the defined deadlines.
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
- Knowledge and understanding of TFS Purchasing Controls Procedure and associated Work Instructions and operates within them to ensure that all purchased product and services conform to specified requirements.
- Ensure a compliant and qualified supply base by conducting supplier evaluations
- Performs other duties as assigned by the Quality Manager.
- Capable of working long hours under stressful conditions, closely and effectively, with people of all levels of the organization to produce necessary results.
- Local car travel and air travel required.
- Capable of handling extended periods of sittings and talking with suppliers on the telephone and utilizing a PC to perform job functions, in addition to Microsoft Professional including outlook and proper email communication.
- 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.
- Participate in Continuous Improvement and support all PPI, Keys and Lean projects.
- Perform other duties and cross training as assigned.
(Position is located in our Marietta, OH Facility. Relocation assistance may be offered)
- Bachelors Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance experience).
- Minimum 3 years experience in manufacturing, design, quality assurance or regulatory assurance.
- Proficiency with Microsoft Excel spreadsheet development and analysis.
- Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
- ASQ Certified Quality Engineer preferred.
- Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
- Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
- Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance.
- Demonstrated collaboration, negotiation & conflict resolution skills.
- Excellent oral communication & report, business correspondence & procedure-writing skills.
- Willing to travel domestically and/or internationally up to 25% of time.
- Working conditions require the ability to sit, stand, walk, bend, climb stairs, work at a computer station and on manufacturing shop floor.
- Ability to frequently lift up to 20 lbs; occasionally lift 40 lbs.
- Ability to work effectively in a team environment.
Thermo Fisher Scientific - 11 months ago
Whether for research, analysis, discovery, or diagnostics, Thermo Fisher Scientific gets the laboratory ready to assist mankind. Created thr...