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Quality Engineer

Company:
Katalyst Healthcares & Life Sciences
Location:
Cleveland, OH, 44101
Posted:
December 26, 2025
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Description:

Responsibilities:

Develop and implement product and process quality control plans.

Lead investigations of customer complaints, returns, and nonconformances.

Conduct inspections, First Article and PPAP submissions, and support audits.

Administer corrective and preventive actions (CAPA) and verify effectiveness.

Use data-driven methods (SPC, Six Sigma) to identify and implement improvements.

Partner with internal and external stakeholders to meet quality and compliance goals. Requirements:

Bachelor's degree in engineering required.

3 5 years' experience in quality engineering or manufacturing.

Knowledge of ISO 9001:2015 (auditing experience required).

Familiarity with IPC 620; AS9100 or ISO 13485 experience a plus.

Strong skills in root cause analysis, CAPA, and statistical tools.

ERP/MRP and Microsoft Office proficiency.

Preferred: ASQ CQE, Internal Auditor certification, industry experience in aerospace, military, or medical devices. Required Skills/Abilities:

Strong analytical and problem-solving skills with attention to detail.

Excellent verbal and written communication, including technical reporting.

Ability to interpret engineering drawings and technical documentation.

Effective project and time management skills with ability to handle multiple priorities.

Skilled at cross-functional collaboration and influencing teams toward quality objectives.

Ability to work independently and lead investigations with minimal oversight.

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