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Quality Engineer

Karwell Technologies

Blue Ash, OH

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JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Delivery Management, Design Failure Mode and Effects Analysis (DFMEA), Design Verification, Documentation, FDA (Food and Drug Administration), FDA Requirements, Failure Mode and Effects Analysis (FMEA), Healthcare Quality, ISO (International Organization for Standardization), Improvement Metrics, Industrial Engineering, Lean Six Sigma, Maintain Compliance, Manufacturing Requirements, Mechanical Engineering, Medical Equipment, Minitab, Multitasking, Problem Solving Skills, Process Capability, Process Validation, Product Development, Project Execution, Project/Program Management, Quality Engineering, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Risk, Risk Analysis, Risk Management, Root Cause Analysis, Six Sigma Certification, Six Sigma Green Belt, Standards Development, Statistics, Surveillance, Systems Maintenance, Team Player, Technical Writing, Time Management, Validation Documentation, Validation Plan, Validation Testing, Variance Analysis, Writing Skills
LOCATION
Blue Ash, OH
POSTED
30+ days ago
Job Description:
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.

Requirements:

  • 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.

About the Company

K

Karwell Technologies

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