Senior Quality & Reliability Engineer (AQE)

• 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. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly ® Engineering? Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.