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Quality Engineer

Posted 8 days ago

Position: Quality Engineer

Location: Issaquah, Washington, 98029

Term: 6 months

Day-to-Day Responsibilities:

  • Act as a single point of contact (person assigned to project team) responsible to ensure that system design meets quality and compliance standards for each milestone
  • Participate in Project Core Team for New Product Introduction – project planning, discussions, decisions, risks identification and mitigations – quality, KPIs and compliance across teams, process and products considering: design, development, usability, reliability, performance, supportability, manufacturability, safety, security, privacy, serviceability, sustainability and cost.
  • Involve in project planning, discussions, decisions, risks identification and mitigations – product and process quality, KPIs and overall compliance oversight.
  • Participate in design reviews - independent oversight and review of project milestones and deliverables throughout product lifecycle. Ensuring that system design meets quality and compliance standards.
  • Participate in product requirements, risk hazard analysis, verifications and validation evidence reviews. Checks and audits to assure completeness of the system verification and validation traceability.
  • Performing independent technical assessment and acceptance of on engineering or production deliverables - Proactively monitor and identify any gaps in design, development (Hardware, Software, Transducer) and supporting processes.
  • Review and approve engineering change orders related to product design control, design history file, TechFile, STED and supporting evidence.
  • Participate in special quality programs for the product quality continuous improvement activities – quality KPIs, dashboard, monitoring, reporting and problem solving.

 

Is this a good fit? (Requirements):

  • Bachelor of Science/Bachelor of Engineering - Bachelor’s degree. ASQ, CQE or other similar certifications a plus.
  • Five (5) plus years of experience working in a GMP, FDA and international medical device regulations.
  • Experience in medical device product lifecycle, software development lifecycle, Design, Development, System Verification & Validation. Good communicator, presentation, influence, and conflict resolution skills.

 

Even better if you have:

  • MDR/STED, Reliability engineering and audit experience.

 

 

If this sounds like the perfect fit, apply today!