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Senior Quality & Reliability Engineer (AQE)
Wilsonville, OR, US
Engineering
Bachelors Degree
Full Time, Temporary
50-52/hr
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Wilsonville, OR, US
50-52/hr
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Senior Quality & Reliability Engineer (Advanced Quality Engineering)
Are you ready to own the quality roadmap for life-changing medical technology?
At our organization, we don’t just “participate” in quality—we steer it. We are looking for a Senior Advanced Quality Engineer (AQE) to act as a methodology leader and strategic partner in our New Product Development (NPD) process. This is a high-influence role where you will bridge the gap between design theory and manufacturing excellence to ensure world-class product reliability.
Your Mission: Drive Excellence Through the Product Lifecycle
Own APQP & Launch Excellence You won’t just be a member of a project team; you will own and steer the quality function from end-to-end.
- Lead APQP execution for multiple complex projects, managing milestones and deliverables through Launch Phases G4–G6.
- Drive “Safe Launch” cross-functionally, ensuring early issues are monitored, corrected, and never repeated.
- Lead process and product release readiness, ensuring validation and control status are impeccable prior to SOP.
Serve as a Methodology Leader Move beyond being a tool user to becoming a team guide. You will challenge and mentor teams on:
- Core Tools: FMEA, Control Plans, MSA, SPC, and Capability studies.
- Approval Processes: Steering FAI, FAAR, and PPAP/PPA submissions.
- Risk Mitigation: Leading high-impact FMEA sessions that ensure risks are mitigated, not just documented, and aligning them with validation results.
Lead Proactive Risk Management As a proactive risk leader, you will identify failures before they happen.
- Conduct project quality risk assessments covering resources, maturity, and customer impact.
- Mitigate risks related to Field Failures and Special/Critical Characteristics (SC/CC).
- Facilitate Reverse PFMEA sessions to close the gap between theory and the shop floor.
Be the Trusted Voice of the Customer Act as the primary customer-quality partner by interpreting Customer Specific Requirements (CSRs) and quality contract clauses. You will utilize customer scorecards to drive preventive actions and serve as the key user for all customer quality portals.
Solve Problems at Scale When complex issues arise, you lead the reaction. Independently apply 8D, 5Why, Ishikawa, and Six Sigma methodologies to drive systemic improvements. You don’t just react; you trigger escalations and ensure permanent fixes are implemented across the organization.
Who You Are
- A Compliance Expert: Confident representing the AQE function during ISO 9001 and industry-specific audits.
- An Informal Leader: You can translate a high-level Quality Strategy into actionable execution and coach your peers through expertise and example.
- An Influential Communicator: You speak clearly and proactively across functions, ensuring everyone is aligned with the quality vision.
- Audit-Ready: You support internal audits and guide teams through the rigorous audit readiness process with confidence.
Why Join Us?
You will be empowered to make decisions that impact the safety and reliability of medical devices used worldwide. This role offers the opportunity to shape AQE practices, contribute to continuous improvement, and grow your career as a respected quality authority.
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