Thermo Fisher Scientific Engineer III, QA in Grand Island, New York
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
Key Responsibilities: Executes planned and systematic activities implemented in a quality system so that quality requirements for products, processes, systems or equipment will be fulfilled. Those activities include the planning and development of processes, procedures and test plans in order to ensure that products manufactured meet internal, customer and regulatory requirements.
Designs quality assurance programs and systems for product and/or process development, manufacturing and testing to ensure product quality and compliance with regulatory requirements.
Leads teams, quality, R&D and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and/or products are developed, tests are conducted and that products, materials, and manufacturing equipment meet required standards.
Uses expert product and process knowledge to contribute to new product and process design teams
Performs complex statistical analysis to analyze trends, and works with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and to contribute to and track data to support at the site level (e.g. yield improvements, CAPA, complaint and scrap reduction)
Leads teams to conduct root cause analysis
Works directly with customers on complex critical quality issues/complaints. Leads issue/complaint resolution
Interfaces with suppliers and vendors to help resolve complex quality issues (e.g., investigations, troubleshoots raw materials issues). Leads resolution of issues
Influences site quality goals & objectives based on in-depth knowledge of quality standards (i.e., ISO, GMP, etc). Act as a subject matter expert when determining clarifications and compliance to written standards, providing additional information for the site to ensure consistent application of quality processes
Leads projects of moderate scope (may be cross functional or involve multiple teams)
Works on complex issues and is guided by expected outcomes
Acts as an advisor/coach to mentor other team members
Provides quality specific training and guidance to the organization (e.g. Six Sigma programs) to correctly identify, define, and quality problems early
Minimum Qualifications (must have):
Bachelor’s degree from accredited college/university or equivalent experience. Preferred Science or Engineering Degree
Minimum of 5 years of relevant quality experience in Medical device or Pharmaceutical industry and 1 year of demonstrated leadership experience preferred (e.g. leading/supervising a project or a team
Quality standards (e.g., 21 CFR Part 820 and ISO 13485)
Compliance with quality standards (e.g., EU GMP, 21 CFR Part 210, 211, 820, ISO 13485, 9001)
Advanced quality tools, (e.g.: SPC, DOE).
Quality tools e.g. FMEA, Risk Analysis,
Site specific software programs (change control notification program, CAPA, etc.).
Global Systems e.g. Trackwise, AGILE, E1/SAP
- Experience with US Pharmacopeia, European Pharmacopeia, Japanese Pharmacopeia and British Pharmacopeia testing
At Thermo Fisher Scientific, each one of our 75,000 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
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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.