Quality Engineer

Quality Engineer

Thermo Fisher Scientific
5-8 years
Not Specified

Job Description


Job Description :
Position Summary:
The Quality Engineer is primarily responsible for the overall quality satisfaction of the customer base, for ensuring establishment of processes that consistently deliver best-in-class quality and for instilling quality awareness in the cross functional team(s). The role includes the assessment of quality, reliability and satisfaction levels driving cross functional and cross organizational teams to improve quality failure analysis design of experiments interaction with engineering, manufacturing, NPI teams, contract manufacturing partner(s), customers and the business units utilizing structured problem solving tools and techniques and the completion of tasks and objectives that support quality improvement.
Besides overall quality engineering, this role will also involved to coach quality staffs and manage the work of quality technician. Work as important quality team representatives to act as a contact window to overseas factories.
Essential Job Functions and Accountabilities:
  • Manage and coach quality technicians/inspectors to develop their skills.
  • Lead cross-functional team members supporting the Customer Feedback/Complaint Handling Process & CAPA process. (Complaint handling)
  • Lead/Coordinate the validation verification and qualification of process/product. (Validation)
  • Strong Root Cause / Corrective Action skills. Develop realistic solutions to meet customer needs and solve problems. Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions. (CAPA)
  • Execute Risk and Impact Assessments (Risk assessment, pFMEA)
  • Interface directly with customers and internal groups. (Collect, communicate customer voice/survey)
  • Drive product and process changes to improve product quality. (ECO)
  • Conduct process audit and product audit to identify improvement opportunity. (Audit)
  • The ability to perform independently and as part of a team.
  • Must be able to influence and negotiate with people and resolve issues/problems.
  • Communicate recommendations and decisions across the organization.
  • Experience with problem solving tools (8D, 5-whys, etc).
  • Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.

Other Job Requirements: Occasional travel is required, including international travel.
Educational Qualifications:
  • Bachelor Degree in Bioscience field Master degree is preferred.

Experience Qualifications:
  • 5 years direct Quality Engineering experience.
  • 3 years experience in Biotech (protein chemistry, molecular biology, immunology, cell biology) and/or pharmaceutical industry in an Engineering, Quality or Regulatory related role.
  • Direct experience of working with ISO 13485 or ISO 9001 and 21CFR820.
  • Excellent communication, written and presentation skills. Proficient with Microsoft tools Word, Excel, Power Point.
  • 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
  • Experience prioritizing conflicting demands
  • Excellent interpersonal, organizational, and influencing skills
  • Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
  • Excellent oral and written communication skill in English, be able to work in a multicultural environment
  • Practical experience in ERP system

Ability to achieve goals independently within a challenging time frame.

Similar Jobs

People Also Considered

Career Advice to Find Better

Simple body text this will replace with orginal content