11720 North Creek Parkway N new 7/22/15 Bothell, WA 98011
Position Title: Quality Engineer
Position Description: Our Bothell client is looking to bring on a Quality Engineer for an FTE role, to their growing team. Junior (1+ yrs.), Mid, and Senior candidates will be considered.
• 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
• This position requires a minimum of an undergraduate degree in Engineering (preferably in Electrical or Mechanical engineering)
• Minimum 1+yrs. for Junior consideration or 5 yrs. medical device exp. for Sr. role
• 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.