Certified Woman & Minority Owned

Quality Engineer


Reference Number: SRWAQE2421

Quality Engineer
experience  Not Disclosed
location  Issaquah, WA
duration  11.0 Months
salary  Not Disclosed
jobtype  Not Disclosed
Industry  Healthcare
Job Description


The candidate should have experience with FDA QSR and ISO13485 requirements and experience in medical device manufacturing quality systems.

Candidate will:

Review and approve new manufacturing processes or changes to manufacturing processes to ensure compliance to established procedures.
Understands regulatory process validation in a medical device manufacturing environment and ensures processes are validated appropriately through review of protocols and resulting validation reports.
Ensures that nonconforming material is dispositioned appropriately by utilizing established non-conforming handling systems.
Understands component and product acceptance requirements and ensures these requirements are implemented appropriately in manufacturing.
Reviews and approves engineering change orders related to supply chain management and manufacturing.
Proactively reviews manufacturing data and participates in special projects related to the continuous improvement activities.
Monitor calibrated equipment to ensure timely calibration and thorough investigation of calibrated equipment received out of tolerance.
Follow lead QE direction and guidance in performing day to day activities where help is needed.

Minimum Requirements: BA/BS required.
Five (5) plus years of experience working in a GMP regulated industry and good working knowledge of FDA and international medical device regulations with three (3) plus years in manufacturing of medical devices. Effective writing and communication skills. ASQ CQE or other certifications a plus.

Note :

9am - 5pm
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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Qualification and Experience
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  • Lorem Ipsum has been the industry's standard dummy text ever since the 1500s
  • when an unknown printer took a galley of type and scrambled it to make a type specimen book.
  • It has survived not only five centuries, but also the leap into electronic typesetting
  • Remaining essentially unchanged. It was popularized in the 1960
Primary Skills
  • Lorem Ipsum is simply dummy text of the printing and typesetting industry.
  • Lorem Ipsum has been the industry's standard dummy text ever since the 1500s
  • when an unknown printer took a galley of type and scrambled it to make a type specimen book.
  • It has survived not only five centuries, but also the leap into electronic typesetting
  • Remaining essentially unchanged. It was popularized in the 1960
Benefits
Healthcare-insurance

Health Insurance

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Flexible Timings

Wages

Pension Scheme

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