Quality Engineer – Medical Devices, NPI & Validation

Pentangle Tech Services | P5 Group; Cincinnati (OH); Presencial; USD 85.000 - 125.000; Jornada completa

Descripción de la vacante

Pentangle Tech Services | P5 Group in Cincinnati, OH is seeking an experienced Quality Engineer to support quality assurance, validation, and manufacturing activities for medical device products in a regulated environment.

The ideal candidate will have 5+ years in quality engineering or related manufacturing roles, with hands-on knowledge of GMP, ISO 13485, FDA regulations, and statistical analysis using Minitab and Excel. This onsite role offers growth and cross-functional collaboration.

Formación

• Bachelor's degree in mechanical engineering or related field.
• Minimum 5 years of quality engineering, validation, or manufacturing engineering experience.
• Medical device industry experience required with GMP/ISO 13485 and FDA familiarity.
• Strong knowledge of validation, risk management, PFMEA/DFMEA, CAPA, and QMS.
• Experience with statistical tools (MSA, SPC, DOE, Process Capability).
• Proficiency with Excel and Minitab for analysis.
• Ability to interpret drawings, GD&T, CMM reports.

Responsabilidades

• Support GMP, ISO 13485, and FDA-regulated environments.
• Analyze data to identify trends and drive improvements.
• Perform CAPA, root cause analysis, and corrective actions.
• Assist manufacturing by resolving quality issues and improving processes.
• Apply statistical tools (MSA, SPC, DOE) and process capability.
• Lead or support process validation (IQ/OQ/PQ).
• Review drawings, GD&T, CMM reports, and dimensional inspection results.
• Support NPI, product validation, and launches.
• Contribute to PFMEA, DFMEA, and Control Plans.
• Collaborate with Manufacturing, Validation, Regulatory, and Supplier Quality.
• Ensure QMS compliance and continuous improvement.

Descripción del empleo

Pentangle Tech Services | P5 Group in Cincinnati, OH is seeking an experienced Quality Engineer to support quality assurance, validation, and manufacturing activities for medical device products in a regulated environment.

The ideal candidate will have 5+ years in quality engineering or related manufacturing roles, with hands-on knowledge of GMP, ISO 13485, FDA regulations, and statistical analysis using Minitab and Excel. This onsite role offers growth and cross-functional collaboration.