Bothell, Washington | Direct Hire
Position Title: Quality Engineer
Position Description: Protingent Staffing has an exciting opportunity with our client in Bothell, WA
- 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 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.