Global Technical Talent
Senior Product Quality Engineer
Global Technical Talent, Atlanta, Georgia, United States, 30383
Overview
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.
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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.
#J-18808-Ljbffr