Senior Quality Engineer - Medical Devices & Design Controls

Katalyst-Healthcares-; Cincinnati (OH); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Katalyst-Healthcares- seeks an experienced Senior Quality Engineer to support medical-device quality systems, design controls, risk management, and regulatory compliance in Cincinnati, Ohio. The role emphasizes CAPA, RCA, non-conformances, and validation activities across the product lifecycle.

You will lead CAPA, document risk assessments, and ensure GMP/ISO 13485 alignment while collaborating with R&D, Regulatory, and Manufacturing teams.

Formación

• Bachelor's degree in engineering, Biomedical Engineering, Life Sciences, or a related technical field
• Minimum of 5 years of quality engineering experience in the medical-device industry or another regulated life-sciences environment
• Strong knowledge of FDA Quality System requirements, GMP, and ISO 13485
• Experience with ISO 14971, design controls, and medical-device risk management
• Hands-on experience with CAPA, root cause analysis (RCA), non-conformances, deviations, and change control

Responsabilidades

• Support new product development and quality deliverables in accordance with medical-device design control requirements.
• Develop, review, and approve design verification and validation protocols, reports, and support documentation.
• Develop and maintain product risk management documentation, including DFMEA, PFMEA, and risk assessments.
• Lead and support CAPA, non-conformance, deviation, root cause analysis, and engineering change-control activities.
• Execute and review process validation, equipment qualification, and IQ/OQ/PQ activities.
• Support internal and external audits, regulatory inspections, and quality system compliance initiatives.
• Analyze quality metrics, investigate trends, and support post-market surveillance and customer complaint investigations.
• Review engineering drawings, product specifications, tolerances, GD&T requirements, and manufacturing documentation.
• Develop and maintain Quality Plans, SOPs, work instructions, and validation documentation.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, Supplier Quality, and cross-functional engineering teams.
• Support technical transfers, manufacturing transfers, and process implementation while ensuring compliance with applicable quality standards.
• Drive continuous improvement initiatives to enhance product quality, process capability, and overall quality system effectiveness.

Conocimientos

CAPA

Root cause analysis

Non-conformance investigations

Design verification and validation

Quality system compliance

Process validation

Regulatory inspections

Quality metrics analysis

Continuous improvement

Educación

Bachelor's degree in Engineering or related field

Descripción del empleo

Katalyst-Healthcares- seeks an experienced Senior Quality Engineer to support medical-device quality systems, design controls, risk management, and regulatory compliance in Cincinnati, Ohio. The role emphasizes CAPA, RCA, non-conformances, and validation activities across the product lifecycle.

You will lead CAPA, document risk assessments, and ensure GMP/ISO 13485 alignment while collaborating with R&D, Regulatory, and Manufacturing teams.