Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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. Communicate with customers regularly to ensure products meet expectations.
What will you do?
- Lead multi-functional team members supporting the Customer Feedback/Complaint Handling Process & CAPA process.
- Lead multi-functional team members supporting internal investigations (NCM, UD) & CAPA process
- Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.
- Complete 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?
- Minimum requirements: HS Diploma and 5 years direct Quality Engineering experience.
- Higher education preferred
- 2 years’ experience in medical device, biotech or pharmaceutical industry in an Engineering, Quality or Regulatory related role required.
- Direct experience of working with ISO 13485 or ISO 9001 and 21CFR820 required.
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 multi-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.
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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