Quality Engineer

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.

• 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.

• 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.

• 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.