Quality Engineer Medical Device Industry Location:Kennesaw, GA | On-site Salary:$70,000$75,000 Employment Type:Full-Time Schedule:MondayFriday, 8:00 AM5:00 PM Openwork issourcing on behalf of our client, a growing organization in the medical device industry. We are seeking aQuality Engineerto join their Regulatory Affairs & Quality Assurance team and support quality activities across the product life cycle. About the Role The Quality Engineer will support quality engineering activities from new product development and commercialization through sustaining changes. This role works closely with cross-functional teams on product quality, process development, validation, risk management, regulatory compliance, and continuous improvement. Key Responsibilities
Support the transfer of new products into production, including process validation activities such asPFMEA, IQ, OQ, and PQ.
Assist with verification and validation test plans, protocols, and reports.
Support compliance with applicableFDA and regulatory requirements.
Review product designs for manufacturability, reliability, testability, and quality requirements.
Participate in product risk management activities, includingrisk assessments, dFMEA, and risk management reports.
Support supplier quality, manufacturing quality, and customer complaint investigations.
Apply statistical tools and techniques to quality and process improvement initiatives.
Manage multiple projects, timelines, and deliverables while working with cross-functional teams.
Develop technical protocols, reports, procedures, and other quality documentation.
Participate in root cause investigations and corrective/improvement activities.
Preferred Qualifications
12+ years of experience in the medical device, life sciences, or related regulated industry.
Bachelor's degree in Engineering, Life Sciences, or a related field. An Associate's degree in Engineering Technology or a related technical discipline may be considered with relevant experience.
Experience withISO 14971 risk management.
Knowledge ofFDA Quality System Regulation, ISO 13485, and medical device regulatory requirements.
Experience withIQ/OQ/PQ process validation.
Familiarity withDOE, SPC, capability analysis, GR&R, sampling plans, hypothesis testing, ANOVA, and other statistical methods.
Experience with statistical software such asMinitabor similar tools.
Knowledge of verification/validation, root cause analysis, and failure investigation.
Exposure to stability, biocompatibility, sterilization, or shipping/transport testing is a plus.
Familiarity withLean and Six Sigmamethodologies is preferred.
Strong technical writing, communication, organization, and problem-solving skills.
The Process: If you are interested and qualified for this position, please APPLY NOW. If you have questions regarding the qualifications, please contact Jessika at JESSIKA.BRIGGS@OPENWORK.COM #OPWTXDH
\nCompany Description
Openwork is a candidate-focused staffing company on a mission to bring ease, accessibility, and thoughtfulness to an industry we’ve held a footing in for 50+ years. We believe there’s more to life than livelihood, but that finding your dream job, career, or team is a really good place to start.
Company Description
Openwork is a candidate-focused staffing company on a mission to bring ease, accessibility, and thoughtfulness to an industry we’ve held a footing in for 50+ years. We believe there’s more to life than livelihood, but that finding your dream job, career, or team is a really good place to start.
Numbers & Facts
Location
Kennesaw, GA
Skills
Analysis Skillsunmatched
Biologyunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Documentationunmatched
ISO (International Organization for Standardization)unmatched
Manufacturingunmatched
Manufacturing Designunmatched
Medical Equipmentunmatched
Medical Organizationsunmatched
Multitaskingunmatched
Problem Solving Skillsunmatched
Process Developmentunmatched
Process Improvementunmatched
Process Validationunmatched
Product Designunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Product Managementunmatched
Product Reviewsunmatched
Product/Service Launchunmatched
Project/Program Managementunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Statistics Softwareunmatched
Sterilizationunmatched
Technical Writingunmatched
Testabilityunmatched
Testingunmatched
Validation Planunmatched
Validation Testingunmatched
Variance Analysisunmatched
Writing Skillsunmatched
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