T

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Product Quality Engineer

Quality EngineeringConfirmed live in the last 24 hours
Full-timeSagamihara, Kanagawa, JapanNo salary listed

About the Job

Requirements

  • A master's degree or equivalent higher degree and at least 3 years of quality assurance experience in an industrial industry, or a bachelor's degree and at least 5 years of such experience.
  • Japanese proficiency at N1 level or above; business-level or native-level Japanese is preferred.
  • Proficiency in English is required for frequent communication with an English-speaking manager; Chinese communication ability is an advantage.
  • Strong knowledge of cGMP, ISO 13485, ISO 9001, and applicable regulatory requirements such as FDA and EMA regulations.
  • Expertise in quality systems, including corrective and preventive action (CAPA), deviation management, change control, risk management, failure mode and effects analysis (FMEA), internal and external audits, advanced problem-solving, and root cause analysis.
  • Availability for up to approximately 25% domestic travel and a flexible work schedule to support global collaboration.

Responsibilities

  • Support product quality and reliability throughout the product lifecycle, from new product development and manufacturing through product changes and customer use.
  • Prevent quality issues, investigate issues when they occur, and drive continuous improvement.
  • Prepare, manage, and maintain documentation in accordance with new product development and internal change-management systems.
  • Troubleshoot product defects.
  • Investigate and resolve quality issues in collaboration with cross-functional teams via email and phone.
  • Communicate with external partners involved in sourcing raw materials and intermediate products.
  • Schedule and facilitate related meetings, domestically and internationally.

Desired Qualifications

  • A degree in engineering, life sciences, chemistry, or a related technical field is preferred.
  • Experience with quality management software and proficiency in Microsoft Office.
  • Experience with validation and qualification protocols.
  • Knowledge of statistical analysis and quality-control tools.
  • Document-control skills.
  • Project-management skills.
  • Troubleshooting and problem-solving skills.
  • Strong oral and written communication skills.
  • Ability to work independently and as part of a team.
  • Interpersonal skills to facilitate cross-functional collaboration.
  • Ability to manage multiple projects concurrently and prioritize work.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size
10,001+
Company stage
IPO
Headquarters
Waltham, MA
Founded
1956

Recently Posted Jobs

Explore more opportunities at Thermo Fisher Scientific

See more jobs