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Quality Engineer

Bothell, WA 98011

Posted: 12/10/2018 Employment Type: Direct Hire Industry: Hardware Job Number: 19210

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.

Job 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

Job Qualifications:

•        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.

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