Quality Engineer

Katalyst-Healthcares-; Cincinnati (OH); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

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.

Qualifications

• 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

Responsabilités

• 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.

Connaissances

CAPA

Root cause analysis

Non-conformance investigations

Design verification and validation

Quality system compliance

Process validation

Regulatory inspections

Quality metrics analysis

Continuous improvement

Formation

Bachelor's degree in Engineering or related field

Description du poste

Job Summary

We are seeking an experienced Senior Quality Engineer to support medical-device quality systems, product development, design controls, risk management, process validation, and regulatory compliance. The ideal candidate will have strong hands-on experience in CAPA, root cause analysis, non-conformance investigations, design verification and validation, and compliance with applicable FDA regulations and ISO standards.

Roles& Responsibilities

• Support new product development and maintain 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.

Education & Experience

• 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, Good Manufacturing Practices (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.