Sr. Product Quality Engineer

Title: Sr. Product Quality Engineer

Location: Atlanta, GA

Duration: 12 Months

100% Onsite

Summary:

We are seeking a Senior Product Quality Engineer to join our product development team. This role will serve as a key quality representative, providing expertise in design controls, risk management, and compliance throughout the product lifecycle. The ideal candidate will have strong experience in the medical device industry, a collaborative mindset, and a deep understanding of regulatory requirements.

This position will lead risk management activities and support various quality engineering functions from product concept through commercialization.

Key Responsibilities:

• Lead and support Design Control activities and ensure timely completion of deliverables
• Define and review product requirements, ensuring they are measurable and verifiable
• Support Design Verification & Validation (V&V) planning and execution
• Lead Risk Management activities, including FMEA, from development through launch
• Assist in test method development and validation (TMV)
• Support manufacturing process development and qualification for new products and changes
• Help define component specifications, sampling plans, and supplier qualifications
• Support biocompatibility and sterilization qualification processes
• Participate in internal and external audits and support QMS improvement initiatives
• Ensure compliance with FDA, EU MDR, and internal quality system requirements
• Work collaboratively across engineering, manufacturing, regulatory, and supply chain teams

Qualifications:

Required:

• Bachelor’s degree in engineering or a related technical field
• Minimum 5 years of experience in R&D, Manufacturing, or Quality Engineering
• At least 2 years supporting product development in the medical device industry
• Experience with risk assessments (FMEA) and test method validation
• Strong understanding of medical device regulations and standards

Preferred:

• Master’s degree in engineering or technical discipline
• Experience with active implantable medical devices
• Knowledge of tools like DOORS, JIRA, or other requirements/risk tracking systems

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.