Quality Engineer - CAPA

Bothell, WA

Posted June 29, 2020

Full-time, Permanent, Day shift 8:00-5:00 with some flexibility

A first-class medical device company that is powerhouse in the life-sustaining ventilator space, is currently looking to add an experienced Quality Engineer (CAPA) to their team. 

This company is experiencing tremendous growth, especially now as the demands of ventilators continues to rise. This is a great opportunity to not only grow your career, but also to make a difference in the world and save countless lives!

They are looking for motivated Quality Engineer (CAPA) to assure products and processes conform to quality standards and establish compliance with the quality management system.

In this Quality Engineer (CAPA) position, you will be responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success, by protecting patient/user safety, meeting business needs through the effective deployment and continuous improvement of the Corrective and Preventive Action system.

This is a full-time, direct hire role that offers competitive benefits.

As a Quality Engineer (CAPA) you will play a critical role 

Not only will you help manufacture a world-class medical device, you will also be helping to save countless lives!

Quality Engineer Key Responsibilities:

  • Actively engages in Corrective and Preventive Action (CAPA) Activities
  • Perform CAPA activities: Mentor/lead product team members through the CAPA process providing guidance to assure a compliant and optimal approach.
  • Assure thorough Root Cause Analysis is completed with the CAPA process
  • Review and approve CAPA documentation throughout all phases of the CAPA process to ensure compliance, continuous improvement, and increased customer satisfaction  
  • Risk Management: facilitate cross-functional collaboration to identify and mitigate product risks to ensure robust medical device design
  • Participates in internal and external audits as the CAPA subject matter expert

Quality Engineer Qualifications include:

    • Bachelor’s degree in an engineering discipline
    • Minimum two years of experience of quality engineering in highly regulated environment (medical device preferred)
    • Experience working directly with Corrective an Preventive Action (CAPA) Investigations
    • Experience with various Root Cause Analysis Methodologies, Training, and Deployment

Pay: $75K-$100K DOE + benefits

Benefits include: medical, dental, and vision coverage, paid time off, and a 401(k) plan.

Location: Bothell, WA (bus accessible, depending on work hours and bus schedules)

Some minimal travel may be required

If you are interested in this role with a leading medical manufacturing company that is making a BIG difference, apply online today. Or call 425-658-2034 to speak to a Recruiter right away.

TERRA is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, national origin, or any other status protected under federal, state, or local law.

About Your Recruiter

Kirsten Poe

I am a Recruiter for TERRA's Technical Division. I love the new adventures that await me every day and the satisfaction and reward of bringing the right client and candidate together. But the best part of my job is giving so many great and talented people a chance to shine! I have a wonderful and supportive husband and stay busy with my three children and one granddaughter.

Named Best of Staffing® nine years running, TERRA specializes in finding the Right Fit™.

Our mission is simple: Success Stories Created Daily.

Reference Number: 93033