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Quality Systems Engineer, Kalrez (R)
- Qnity (Newark, DE)
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Are you looking to power the next leap in the exciting world of advanced electronics? Do you want to help solve problems that drive success in the rapidly evolving technology and connectivity landscape? Then bring your problem-solving, passion, and creativity to help us power the next leap in electronics.
At **Qnity** , we’re more than a global leader in materials and solutions for advanced electronics and high-tech industries – we’re a tight-knit team that is motivated by new possibilities, and always up for a challenge. All our dedicated teams contribute to making cutting-edge technology possible. We value forward-thinking challengers, boundary-pushers, and diverse perspectives across all our departments, because we know we play a critical role in the world enabling faster progress for all. Learn how you can start or jumpstart your career with us.
Kalrez** ® **Quality Systems Engineer!
Are you passionate about driving excellence and ensuring world-class quality standards? We’re looking for a **Kalrez** ® **Quality Systems Engineer** to lead critical initiatives that keep our Quality Management System (QMS) strong, compliant, and continuously improving.
In this role, you’ll be the **go-to expert** for quality systems, spearheading CAPA processes, audits, management reviews, and quality planning. You’ll collaborate across teams, influence change, and foster a culture where quality isn’t just a requirement — it’s a mindset.
What You’ll Do
+ Ensure compliance with ISO9001, AS9100D, Nadcap, AS13100, and other key standards.
+ Lead the CAPA process from investigation to effectiveness verification.
+ Plan and execute internal audits, support external audits with confidence.
+ Organize management reviews to evaluate QMS performance and drive improvements.
+ Develop quality plans for new products and process changes.
+ Analyze data to identify trends and implement proactive solutions.
+ Promote quality awareness and accountability across the organization.
+ Support product recall activities and regulatory interactions.
+ Mentor and motivate team members, fostering collaboration and growth.
What We’re Looking For
+ Bachelor’s degree + 5 years in the medical device industry (or equivalent experience).
+ Strong knowledge of ISO 9001, ISO 17025, AS9100, AS13100.
+ Internal Auditor Certification required; Lead Auditor preferred.
+ Proven experience leading root cause analysis RCA, managing CAPA processes and conducting audits.
+ Excellent organizational, analytical, and leadership skills.
+ Clear communicator with a proactive, hands-on approach.
Skills That Set You Apart
+ Expertise in QMS and continuous improvement tools (SPC, Six Sigma).
+ Strategic thinker who thrives in a collaborative environment.
+ Ability to influence and drive changes across global teams.
Why You’ll Love Working Here
+ Be part of a team that values innovation, quality, and continuous improvement.
+ Opportunities for professional growth and certification advancement.
+ A culture that encourages collaboration, accountability, and making an impact.
\#LI-RS1
Join our Talent Community (https://careers.qnityelectronics.com/us/en/jointalentcommunity) to stay connected with us!
Qnity is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class. If you need a reasonable accommodation to search or apply for a position, please visit our Accessibility Page for Contact Information (https://www.qnityelectronics.com/accessibility.html) .
Qnity offers a comprehensive pay and benefits package. To learn more visit the Compensation and Benefits page (https://careers.qnityelectronics.com/us/en/compensation-and-benefits-final) .
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