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Quality Engineer

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  • ID: 496545
  • Posted: 11/24/2021
  • Location: Issaquah, WA
  • Category: Pro - Engineering
  • Job Type: Temporary
  • Duration: 9 - 12 Months

Description

Acara Solutions is looking for an Quality Engineer for our Client located in Issaquah, WA

  • 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.

Pay and Benefits:

  • The Salary for this position is $ 46.26 per hour (Max Pay rate).
 
Job Requirements

 
Required Skills / Qualifications:
  • Bachelor's Degree (BA/BS)
  • Minimum of 5 years' experience working in a GMP regulated industry
  • Minimum of 5 years' experience with FDA QSR and ISO13485 requirements and experience in medical device manufacturing quality systems.
  • Minimum of 3 years' experience in manufacturing of medical devices
Preferred Skills / Qualifications:
  • Good working knowledge of FDA and international medical device regulations 
  • Effective writing and communication skills. ASQ CQE or other certifications 

Additional Information:

  • Upon offer of employment, the individual will be subject to a background check and a drug screen

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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