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Quality Engineer

Bothell, Washington | Direct Hire

Post Date: 04/25/2017 Job ID: 16778 Industry: Hardware

Position Title: Quality Engineer

Position Description:  Protingent Staffing has an exciting opportunity with our client in Bothell, WA

Responsibilities:
  • Support daily production activities and review change orders for adequacy
  • Maintain current knowledge of federal, state, and international regulations regarding GMP, ISO, MDD, and quality assurance
  • Ensure all documentation, reports, tests and results meet the requirements of Regulatory Filings and Technical files for CE filings
  • Work with manufacturing engineering to plan, execute, and document process validations
  • Identify and communicate product safety requirements to design team
  • Participate in supplier assessment, corrective action, and audits
  • Act as the quality representative for inspection and Material Review Board (MRB) activities
  • Participate in Design Control activities including specification development, V&V, Design Transfer, compliance to GMP requirements, design and program reviews etc.
  • Participate in the project risk management activities including establishing risk documents such as risk management plans/reports and risk analysis
  • Contribute to formalizing and instituting the quality system, writing procedures, and utilizing quality tools and techniques to ensure product compliance to CE marking and QSR requirements
  • Experience with generating technical files is preferred
  • Plan, schedule, and complete projects in an aggressive, sense of urgency manner consistent with corporate objectives
  • Manage sterilization procedures and maintenance activities and the environmental monitoring program
  • 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.

Other Responsibilities and Duties:
  • Lead in supplier quality audits
  • Lead internal audits
  • Participate in Regulatory Assurance activities as required
  • Participate in audits including internal, USFDA and Notified Body

Minimum Requirements:
  • Minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering) or equivalent experience.
  • Minimum 5 years in a medical device industry.
  • Extensive knowledge and experience in medical 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

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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