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Sr. Quality Engineer

Seattle, Washington 98011 | Direct Hire

Post Date: 12/21/2017 Job ID: 17875 Industry: Hardware

Position Title:  Senior Quality Engineer

Position Description:  Protingent Staffing has an exciting direct hire opportunity with our client in Seattle, Washington for an experienced  Senior Quality Engineer. The Senior  Quality Engineer is expected to proactively provide innovative Quality solutions and leadership based on their extensive knowledge and experience in medical device Quality Engineering. This individual is proficient in standards, safety agency compliance, risk management, product development, and verification activities, and all Quality processes specific to our industry.

Job Requirements:
  • Support daily production activities and review change orders for adequacy
  • Provide input from concept to production on all quality related issues
  • Develop Quality Engineering deliverables in compliance with applicable standards
  • Maintain current knowledge of federal, state, and international regulations regarding safety agency, GMP, ISO, MDD, and quality assurance 
  • Participate in the project risk management activities including establishing risk documents such as risk management plans/reports and risk analysis 
  • Ensure all documentation, reports, tests and results meet the requirements of Regulatory Filings and Technical files for CE filings 
  • Identify and communicate product safety requirements to design team 
  • Work with manufacturing engineering to plan, execute, and document process validations
  • Support daily production activities and review change orders for adequacy
  • Participate in supplier assessment, corrective action, and audits
  • Act as the quality representative for inspection and Material Review Board (MRB) activities
  • Participate in the SOP writing and ensure that all employees follow written SOPs and process specifications
  • Participate in product complaint and corrective action system. Perform and support complaint and CAPA activities.
  • Plan, schedule, and complete projects in an aggressive, sense of urgency manner consistent with corporate objectives
  • Participate in Regulatory activities as required
  • Participate in audits including internal, FDA and Notified Body

Job Qualifications:
  • This position requires a minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience.
  • Medical device industry background preferred.
  • Extensive knowledge and experience in device development and manufacturing, from concept to release and distribution.
  • Extensive knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601. 
  • Strong collaboration and development skills.
  • Proactive, team player, enthusiastic, with high work ethics
  • PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point)
  • High level of attention to details, capable of efficient use of time and project management skills essential

Work Environment:
  • Most work will be performed in an office and light-manufacturing environment. The noise level in the work environment is usually low to moderate.

 

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

 

 

 

Jeff Morgante

I have an ability to connect with engineers easily, with an engineering background myself, I can relate and communicate using the same language. I have been working in Technical staffing at Protingent for more than 5 years. I have two dogs, Kaleb & Kayce and two cats, Mika and Shiloh. I am originally from upstate New York, but love living in the Pacific Northwest for 13 years! I have a passion for cars, old and new.

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