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.