Position: Quality Engineer
Location: Issaquah, Washington, 98029
Term: 6 months
- Act as a single point of contact (person assigned to project team) responsible to ensure that system design meets quality and compliance standards for each milestone
- Participate in Project Core Team for New Product Introduction – project planning, discussions, decisions, risks identification and mitigations – quality, KPIs and compliance across teams, process and products considering: design, development, usability, reliability, performance, supportability, manufacturability, safety, security, privacy, serviceability, sustainability and cost.
- Involve in project planning, discussions, decisions, risks identification and mitigations – product and process quality, KPIs and overall compliance oversight.
- Participate in design reviews - independent oversight and review of project milestones and deliverables throughout product lifecycle. Ensuring that system design meets quality and compliance standards.
- Participate in product requirements, risk hazard analysis, verifications and validation evidence reviews. Checks and audits to assure completeness of the system verification and validation traceability.
- Performing independent technical assessment and acceptance of on engineering or production deliverables - Proactively monitor and identify any gaps in design, development (Hardware, Software, Transducer) and supporting processes.
- Review and approve engineering change orders related to product design control, design history file, TechFile, STED and supporting evidence.
- Participate in special quality programs for the product quality continuous improvement activities – quality KPIs, dashboard, monitoring, reporting and problem solving.
Is this a good fit? (Requirements):
- Bachelor of Science/Bachelor of Engineering - Bachelor’s degree. ASQ, CQE or other similar certifications a plus.
- Five (5) plus years of experience working in a GMP, FDA and international medical device regulations.
- Experience in medical device product lifecycle, software development lifecycle, Design, Development, System Verification & Validation. Good communicator, presentation, influence, and conflict resolution skills.
Even better if you have:
- MDR/STED, Reliability engineering and audit experience.
If this sounds like the perfect fit, apply today!