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Company Overview 

Yoh, a Division of Day & Zimmermann, delivers talent and workforce solutions in Aerospace & Defense, Engineering, Information Technology, Life Sciences and Telecommunications, helping clients address complexities of managing cost, risk, quality and value of the entire workforce. Founded in 1940, Yoh is headquartered in Philadelphia, PA and operates from 75 locations.

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Quality Assurance Engineer - Medical Devices
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Job Description 

Yoh Scientific has an opening for a QA Engineer - Medical Devices in Bellevue, WA.

Our customer is a company that was founded in 1994 to develop a commercially viable light-activated drug product to treat patients with solid tumor cancers. The company has built a strong development organization with an efficient team overseeing engineering, clinical trials, manufacturing, and regulatory/legal affairs.

Description:

  • Device / Combination Product Quality Engineer. Supports Medical Device Product Development and Quality Systems compliance to applicable regulations and standards including: Quality System Regulations (21CFR Part 820), ISO 13485:2003, Medical Device Directive, cGMP (21CFR Part 211)

Responsibilities:

  • Plan and implement medical device design verification and design validation activites including development of test protocols, validation of test methods, and review and approval of reports
  • Coordinate design verification and design validation activities with both internal and external resources.
  • Facilitate and contribute to medical device risk management activities
  • Provide QA support for compilation, review, and approval of device design history file
  • Provide QA oversight of manufacturing process validation activities at contract manufacturers.
  • Support design transfer activities at contract manufacturers
  • Support production test system design and implementation at contract manufacturers
  • Develop and implement internal quality systems procedures compliant to device quality system regulations and standards, and drug manufacturing regulations.
  • Coordinate and track device complaint investigations
  • Conduct internal and external (supplier) quality audits
  • Travel up to 20%
  • Other duties as assigned
  • Contacts: Primary contacts with Senior Quality Assurance Manager, Device Design Engineering, Device Manufacturing Engineering, Contract Manufacturer Quality and Manufacturing personnel, Regulatory Compliance and Document Control Personnel, Preclinical and Research Scientists/Engineers.
 


Job Requirements 

  • Minimum of 5 years experience in direct support of quality systems in class II / class III medical device development and manufacturing.
  • Experience with European Medical Device Directive / CE marking of medical devices
  • Bachelors degree in an engineering discipline.
  • Excellent organizational and record keeping skills
  • Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative and management personnel
  • Internal and external quality auditing experience is desirable • ASQ certification (CQA, CQE, CQPA) desirable
  • Experience in both drug and device quality management systems is desirable. MS Word, Excel, and some experience in database management 

 

Discover all that’s possible with Yoh Scientific. Apply now.

 

 


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Partnering with Yoh

In addition to great career opportunities, consulting with Yoh comes with its perks:

  • Competitive compensation plans
  • Wide variety of benefit options
  • Yoh Advantage - our consultant rewards program that offers discounts and perks at leading companies and with national brands exclusively for Yoh



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