5+ years of experience
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Employment Type:
Full time
Job Category:
Senior Quality Engineer at Bothell WA
(This job is no longer available)
Software Specialists | Bothell, WA
Grad Date

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Job Description


This is Rohini with SSI, We have an immediate opening for Senior Quality Engineer with our Direct client. If you are interested please reach me with your Updated Resume

Title: Senior Quality Engineer
Duration: 6months + (most likely will extend after that)

Location: Bothell WA

Pay: $50/hr on W2


  • More than 5 years professional experience.


  • Bachelor's Degree or equivalent work experience in FDA regulated industry (Medical Device, Cosmetics, Pharma).


  • Responsible for identifying regulatory requirements and standards for new product development, product updates, and new country launches. Develops protocols for verifying compliance to the standards and oversee testing at contract labs to collect evidence of compliance to the regulatory and standards requirements.
  • Additionally, review product complaints from international consumers and assess for necessary containment actions and any regulatory reporting requirements.
  • Familiarity with the following Regulations and Standards desired:
    • Regulations: 21CFR820, ISO 13485, EU 1223/2009, EU MDD & MDR.
    • Standards: ISO 10993, USP 661, REACH, RoHS, EN 55014, EN 62233, FCC Part 15, FCC Part 18, UL 60950, UL 1642, UL 1431, EN 60950, EN 62133, IEC 60335, ISO 20127


Applicants must be eligible to work in the specified location

About Software Specialists

SCS, Inc. has for thirty years successfully provided a wide range of businesses with effective software solutions. SCS principals authored software which evolved into nationally recognized financial packages. SCS focuses on mid-range markets, but its expertise and support expands to multinational corporations, Fortune 500 companies and large government entities. SCS's President was elected President of the prestigious Software Council of Southern California in 1998, acknowledging decades of solid SCS accomplishment. SCS is the largest Navision Solution Center in the West US and is among the leading Solution Centers for Navision Software worldwide. We have implemented and customized Navision Software in over 350 companies in over 20 different industries.