Quality Engineer

Openwork; Kennesaw (GA); On-site; USD 70,000 - 75,000; Full time

Job summary

Openwork is seeking a Quality Engineer for a medical device client in Kennesaw, GA. This on-site role supports the Regulatory Affairs & Quality Assurance team across the product lifecycle, including design transfer, validation, and risk management.

Responsibilities include coordinating PFMEA/IQ/OQ/PQ activities, reviewing designs for manufacturability, and ensuring compliance with FDA and ISO 13485 requirements. Strong communication and documentation skills are essential.

Qualifications

• Experience in medical device or regulated life sciences environments.
• Strong knowledge of risk management and FDA/ISO requirements.
• Experience with design transfer, validation, and process improvement.
• Excellent documentation and cross-functional team collaboration.

Responsibilities

• Support transfer of new products into production with process validation (PFMEA, IQ, OQ, PQ).
• Assist verification/validation test plans, protocols, and reports.
• Ensure compliance with FDA and regulatory requirements.
• Participate in risk assessments, CAPAs, and supplier/customer investigations.

Skills

Quality engineering

Statistical analysis

Process validation

Risk management

Documentation/writing

Cross-functional teams

FDA/ISO knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Minitab

DOE methods

Job description

Quality Engineer – Medical Device IndustryLocation: Kennesaw, GA | On-siteSalary: $70,000–$75,000Employment Type: Full-TimeSchedule: Monday–Friday, 8:00 AM–5:00 PMOpenwork is sourcing on behalf of our client, a growing organization in the medical device industry. We are seeking a Quality Engineer to join their Regulatory Affairs & Quality Assurance team and support quality activities across the product life cycle.About the RoleThe 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 ResponsibilitiesSupport the transfer of new products into production, including process validation activities such as PFMEA, IQ, OQ, and PQ.Assist with verification and validation test plans, protocols, and reports.Support compliance with applicable FDA and regulatory requirements.Review product designs for manufacturability, reliability, testability, and quality requirements.Participate in product risk management activities, including risk 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 Qualifications1–2+ 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 with ISO 14971 risk management.Knowledge of FDA Quality System Regulation, ISO 13485, and medical device regulatory requirements.Experience with IQ/OQ/PQ process validation.Familiarity with DOE, SPC, capability analysis, GR&R, sampling plans, hypothesis testing, ANOVA, and other statistical methods.Experience with statistical software such as Minitab or 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 with Lean and Six Sigma methodologies 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 [e-mail]#OPWTXDH