Quality Engineer

Quality Engineer Katalyst Healthcares & Life Sciences - 4.0 Blue Ash, OH Job Details Contract 6 hours ago Qualifications Regulatory inspections Bachelor's degree in mechanical engineering Statistics Document review (document control) Bachelor's degree in industrial engineering Hypothesis testing Technical documentation ISO standards Quality control statistical data analysis Engineering Regulatory compliance Statistical Process Control Mechanical Engineering Compliance audits & assessments Corrective and preventive actions (CAPA) Quality management GMP Master's degree Minitab Analysis skills Bachelor's degree Quality control documentation Continuous improvement Industrial Engineering Master's degree in mechanical engineering Design failure mode and effects analysis (DFMEA) Technical writing Quality standards in production Design controls

Lean Six Sigma Green Belt Full Job Description 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.