Global Technical Talent, an Inc. 5000 Company
Senior Product Quality Engineer
Global Technical Talent, an Inc. 5000 Company, Atlanta, Georgia, United States, 30383
Primary Job Title
Senior Product Quality Engineer
Alternate/Related Job Titles
Design Quality Engineer
Product Development Quality Engineer
Medical Device Quality Engineer
R&D Quality Assurance Engineer
Location Atlanta, GA
Onsite Flexibility Onsite
Contract Details
Position Type:
Contract
Contract Duration:
12 months
Start:
As Soon As Possible
Shift/Hours:
8:00 AM - 5:00 PM
Job Summary The 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 Responsibilities
Lead 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 Experience
Bachelor’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 Qualifications
Advanced 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 Skills
Design Control & Risk Management
Verification & Validation (V&V)
Medical Device Quality Systems
Preferred Skills
FMEA & Risk Documentation
Test Method Development
Supplier Quality & Process Validation
Regulatory Compliance (FDA, EUMDR)
Cross‑functional Team Leadership
Additional Skills
QMS/EMS Compliance
Audit Support
Requirements Management (DOORS)
Problem Tracking (JIRA)
Statistical Methods Application
Benefits
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About 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, GTT highly values diverse and inclusive workplaces. Our clients include 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.
Job Number: 25‑27412
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Senior Product Quality Engineer
Alternate/Related Job Titles
Design Quality Engineer
Product Development Quality Engineer
Medical Device Quality Engineer
R&D Quality Assurance Engineer
Location Atlanta, GA
Onsite Flexibility Onsite
Contract Details
Position Type:
Contract
Contract Duration:
12 months
Start:
As Soon As Possible
Shift/Hours:
8:00 AM - 5:00 PM
Job Summary The 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 Responsibilities
Lead 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 Experience
Bachelor’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 Qualifications
Advanced 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 Skills
Design Control & Risk Management
Verification & Validation (V&V)
Medical Device Quality Systems
Preferred Skills
FMEA & Risk Documentation
Test Method Development
Supplier Quality & Process Validation
Regulatory Compliance (FDA, EUMDR)
Cross‑functional Team Leadership
Additional Skills
QMS/EMS Compliance
Audit Support
Requirements Management (DOORS)
Problem Tracking (JIRA)
Statistical Methods Application
Benefits
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About 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, GTT highly values diverse and inclusive workplaces. Our clients include 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.
Job Number: 25‑27412
#J-18808-Ljbffr