Quality Engineer II
Job Title: Quality Engineer II
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.
Location/Division Specific Information
Ogden, Utah - Single Use Technologies
How will you make an impact?
The Quality Engineer II will lead investigations, development of investigation plans and assist in development of corrective action plans of quality issues related to customer complaints, corrective action requests and quality improvement requests. Interface 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
- Strong Root Cause / Corrective Action skills.
- Drive product and process changes to improve product quality.
- The ability to perform independently and as part of a team.
- Must be able to influence and negotiate with people and resolve issues.
- Communicate recommendations and decisions across the organization.
- Experience with problem solving tools (8D, 5-whys, cause and effect, etc).
- Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.
How will you get here?
- Bachelor's degree in Engineering field or 5 years direct Quality Engineering experience.
- 5 years' experience in medical device, biotech or pharmaceutical industry in an Engineering, Quality or Regulatory related role.
- Direct experience of working with ISO 13485 or ISO 9001 and 21CFR820
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.
- 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 skills
- 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, Visio, Teams; MiniTab.
- ASQ certification is desired.
At Thermo Fisher Scientific, each one of our 70,000 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
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.
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