Quality Engineer

Job Summary:

Medical Device Quality Engineer with 4+ years of experience supporting Quality Management Systems (QMS) in regulated medical device and pharmaceutical environments. Experienced in complaint handling, CAPA, non-conformance investigations, post-market surveillance support, risk management, and regulatory compliance. Skilled in applying FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards to ensure quality-compliant project execution. Proven ability to collaborate with cross-functional teams, support audits and inspections, and manage quality deliverables across multiple projects within established timelines.

Roles & Responsibilities:

• Support and maintain Quality Management System (QMS) processes in compliance with FDA regulations, ISO 13485, and medical device quality standards.
• Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, Design, and Project Management to deliver quality-compliant outcomes.
• Interpret and apply medical device regulations and standards to product development, complaint handling, validation, and risk management activities.
• Drive complaint handling investigations, post-market surveillance activities, non-conformance (NC) investigations, and CAPA implementation/closure.
• Conduct root cause analysis using quality tools such as FMEA, Fishbone Analysis, 5 Whys, SPC, and statistical analysis techniques.
• Support audits and regulatory inspections by preparing quality documentation, addressing observations, and ensuring timely closure of corrective actions.
• Perform and review risk assessments in accordance with ISO 14971, including DFMEA, UFMEA, Risk Management Plans, and Risk Reports.
• Support Design Control and DHF remediation activities, ensuring compliance with regulatory and quality requirements.
• Author, review, and execute validation documentation including IQ, OQ, PQ, TMV protocols, and validation reports.
• Monitor complaint trends and quality metrics to identify improvement opportunities and reduce recurring quality issues.
• Manage multiple quality deliverables and ensure projects are completed within timelines while meeting compliance and quality objectives.
• Support 510(k) documentation, validation activities, and continuous improvement initiatives within regulated medical device environments.

Education & Experience:

• Master's degree in Industrial Engineering from Southern Illinois University Edwardsville, IL.
• Bachelor's degree in Mechanical Engineering from KL University, India.
• 4+ years of experience in Medical Device and Pharmaceutical Quality Engineering roles.
• Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, cGMP, and medical device quality regulations.
• Hands-on experience with complaint handling, CAPA, non-conformance investigations, risk management, validation, and DHF remediation.
• Experience supporting Design Verification & Validation (V&V), process qualification, and quality system compliance activities.
• Proficient in quality and statistical tools including Minitab, SPC, Process Capability Studies, Hypothesis Testing, ANOVA, and Gauge R&R.
• Skilled in QMS platforms and documentation systems including ETQ, MasterControl, and TrackWise.
• Lean Six Sigma Green Belt Certified with strong analytical, problem-solving, and technical writing abilities.