Quality Systems Engineer, Kalrez

Quality Systems Engineer, Kalrez®

A global leader in advanced electronics and high‑tech materials, Qnity empowers front‑line teams to solve complex problems and innovate across the sector. We value forward‑thinking challengers, boundary‑pushers, and diverse perspectives.

• Ensure compliance with ISO 9001, AS9100D, Nadcap, AS13100, and additional key standards.
• Lead the CAPA process from investigation through effectiveness verification.
• Plan and execute internal audits and support external audit readiness.
• Organize management reviews to assess QMS performance and drive improvement.
• 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.

• Bachelor’s degree and at least 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 with root‑cause analysis, CAPA management, and audit execution.
• Excellent organizational, analytical, and leadership skills.
• Clear communicator with a proactive, hands‑on approach.

• Expertise in QMS and continuous improvement tools (SPC, Six Sigma).
• Strategic thinker who thrives in collaborative environments.
• Ability to influence and drive change across global teams.

• Part of a team that values innovation, quality, and continuous improvement.
• Opportunities for professional growth and certification advancement.
• Culture that encourages collaboration, accountability, and impact.

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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, please visit our Accessibility Page for contact information.

Qnity offers a comprehensive pay and benefits package. To learn more, visit the Compensation and Benefits page.

Mid‑Senior level

Full‑time

Quality Assurance – Semiconductor Manufacturing