Senior Product Quality Engineer

Primary Job Title:Senior Product Quality EngineerAlternate/Related Job Titles:Design Quality EngineerProduct Development Quality EngineerMedical Device Quality EngineerR&D Quality Assurance EngineerLocation:Atlanta, GAOnsite Flexibility:OnsiteContract Details:Position Type: ContractContract Duration: 12 months Start: As Soon As PossibleShift/Hours: 8:00 AM - 5:00 PMJob SummaryThe Senior Product Quality Engineer serves as the technical quality representative within a product development team, ensuring that design and process activities meet regulatory standards and customer expectations. This position leads risk management and design control initiatives to ensure product safety, compliance, and performance across the full product lifecycle. The ideal candidate is a well-rounded engineering professional with strong experience in medical device quality systems, development processes, and cross-functional collaboration.Key ResponsibilitiesLead and/or support the on-time completion of Design Control deliverables.Develop objective, measurable, and verifiable product requirements aligned with quality standards.Plan and execute Design Verification and Validation (V&V) activities, including investigations and corrective actions.Lead Risk Management processes from concept through commercialization, including FMEA and risk documentation.Develop and validate test methods to support new product development.Collaborate with manufacturing to develop and qualify new processes and design changes.Establish component specifications, supplier sampling plans, and vendor qualifications.Support biocompatibility and sterilization validation for new or modified devices.Participate in audits and quality system improvement activities in alignment with QMS and EMS requirements.Ensure compliance with FDA, EUMDR, and other applicable regulatory standards.Maintain effective cross-functional communication with engineers, suppliers, and regulatory stakeholders.Required ExperienceBachelor’s Degree in Engineering or a related technical field.Minimum 5 years’ experience in R&D, Manufacturing, or Quality Engineering, including at least 2 years supporting product development.Proven experience in medical device quality systems and regulatory compliance.Demonstrated ability in test method development, validation, and risk assessment (FMEA).Preferred QualificationsAdvanced degree in an Engineering or Technical field.Experience with active implantable medical devices.Familiarity with requirements management tools (e.g., DOORS) and issue tracking systems (e.g., JIRA).Working knowledge of statistical analysis for verification and validation processes.Required SkillsDesign Control & Risk ManagementVerification & Validation (V&V)Medical Device Quality SystemsPreferred SkillsFMEA & Risk DocumentationTest Method DevelopmentSupplier Quality & Process ValidationRegulatory Compliance (FDA, EUMDR)Cross-functional Team LeadershipAdditional SkillsQMS/EMS ComplianceAudit SupportRequirements Management (DOORS)Problem Tracking (JIRA)Statistical Methods ApplicationBenefitsMedical, Vision, and Dental Insurance Plans401k Retirement FundAbout the Client:A global healthcare innovator dedicated to improving lives worldwide. The organization develops and markets medical devices, diagnostics, nutrition products, and branded generics, focusing on advancing technology to address critical healthcare challenges and empower people to live healthier lives.About GTT:GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!Job Number: 25-27412