Thermo Fisher Scientific Quality Engineer II in Grand Island, New York
When you're a 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.
How will you make an impact?
The Quality Engineer II will lead develop investigation plans, lead investigation execution, and assist in development of corrective action plans of quality issues related to customer complaints, corrective action requests and quality improvement requests. Interfaces with customers regularly to ensure products meet expectations.
What will you do?
Lead cross-functional team members supporting the Customer Feedback/Complaint Handling Process & CAPA process.
Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.
Execute Risk and Impact Assessments
Interface directly with customers and internal groups.
Develop realistic solutions to meet customer needs and solve problems
Drive product and process changes to improve product quality.
Communicate recommendations and decisions across the organization.
Use problem solving tools (8D, 5-whys, cause and effect, etc) to drive resolutions.
Lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.
How will you get here?
A minimum of a High School Diploma or GED is required; Bachelor's Degree in related Science/Engineering field is preferred.
A minimum of 3 years of experience in a manufacturing, quality or sciences role within a regulated environment (medical device, biotech or pharmaceutical, etc.).
Experience in direct Quality Engineering or Regulatory role preferred.
Direct experience working under federal manufacturing regulations is required
Direct experience of working with ISO 13485 and 21CFR820 is preferred
Knowledge, Skills, Abilities
Strong analytical, problem solving, and teamwork skills are required.
Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements.
Strong Root Cause / Corrective Action skills.
Ability to analyze and process data and draw the appropriate conclusions.
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processes
Understanding of plastics- materials, properties, manufacturing processes, and product assembly.
Experience prioritizing conflicting demands
Excellent interpersonal, organizational, and influencing skill.
The ability to perform independently and as part of a team.
Ability to analyze and process data, and draw the appropriate conclusions
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Excellent communication, written and presentation skills. Proficient with Microsoft tools; Word, Excel, Power Point, Teams.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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