Quality Engineer..

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

Job Summary

We are seeking an experienced

Quality Engineer

Location: Cincinnati, Ohio (Onsite)
Duration: 24 Months

Job Summary

We are 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 experience with quality systems, process validation, risk management, statistical analysis, and new product introduction while working closely with cross-functional engineering and manufacturing teams.

Key Responsibilities

• Support quality and compliance activities within GMP, ISO 13485, and FDA-regulated manufacturing environments.
• Analyze quality and manufacturing data to identify trends and support continuous improvement initiatives.
• Perform root cause analysis, troubleshooting, and corrective/preventive action (CAPA) activities.
• Support manufacturing operations by resolving quality issues and improving production processes.
• Apply statistical quality tools including MSA, SPC, DOE, Process Capability Analysis, and Reliability Studies.
• Execute process validation activities including TMV, IQ, OQ, PQ, FAI, and Process Characterization.
• Review engineering drawings, GD&T, CMM reports, and dimensional inspection results.
• Perform dimensional and statistical analysis using Excel, Minitab, or similar tools.
• Support New Product Introduction (NPI), product validation, and commercial launch activities.
• Participate in PFMEA, DFMEA, Gage R'R, Risk Assessments, and Control Plan development.
• Support supplier quality activities including component qualification and process capability assessments.
• Collaborate with Manufacturing, R'D, Validation, Regulatory Affairs, and Supplier Quality teams.
• Ensure compliance with Quality Management System (QMS) requirements and drive continuous improvement initiatives.

Required Qualifications

• Bachelor's Degree in Mechanical Engineering or a related engineering discipline.
• Minimum 5 years of experience in Quality Engineering, Validation Engineering, or Manufacturing Engineering.
• Medical device industry experience is required.
• Experience working within GMP, ISO 13485, and FDA-regulated environments.
• Strong knowledge of process validation, risk management, PFMEA, DFMEA, CAPA, and Quality Management Systems.
• Experience with statistical analysis tools such as MSA, SPC, DOE, and Process Capability.
• Ability to interpret engineering drawings, GD&T, CMM reports, and quality documentation.
• Proficiency with Excel, Minitab, or similar statistical software.
• Excellent analytical, problem-solving, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Experience supporting surgical products, implantable devices, or other complex medical devices.
• Experience with New Product Introduction (NPI) and product commercialization.
• Six Sigma Green Belt or Black Belt certification.
• Experience with supplier quality, component qualification, and supplier validation activities.