Staff Design Quality Engineer

Becton Dickinson NA; Covington (GA); On-site; USD 110,000 - 150,000; Full time

Job summary

Becton, Dickinson and Company (BD) in Georgia seeks a senior Quality Engineer to provide technical leadership across quality teams. You will guide design controls, risk management, and regulatory submissions while shaping QA processes and supplier qualifications.

Role emphasizes design verification/validation, DOE, CAPA, and cross-functional collaboration to ensure robust product development and manufacturing quality in a fast-paced medical technology environment.

Qualifications

• BS in Engineering with 8+ years in Quality Engineering including design controls, product/process validation, risk management and problem solving.
• MS in Engineering with 6+ years in Quality Engineering including design controls, product/process validation, risk management and problem solving.

Responsibilities

• Provide technical leadership to Quality Engineers, Technicians, and Inspectors.
• Lead quality engineering projects to enhance quality systems, procedures and compliance.
• Develop test protocols and reports for regulatory submissions (FDA 510(k), PMA, CE).
• Support early-stage product development with quality expertise.
• Develop and maintain Risk Management Files with cross-functional teams.
• Create/execute Design Verification and Validation protocols and analyze results.
• Contribute to design control documentation (DQ, DP, DVP, DD) per BD processes.
• Coordinate external lab testing (cleaning, reprocessing validations).
• Develop inspection/test methods and plans for components and finished products.
• Support shelf-life studies and test protocols for expiration dating.
• Perform method validations and ensure data integrity.
• Lead supplier qualification, mold validation, and DOE studies.
• Support process transfers and scale-up to production.
• Review/disposition nonconforming materials/products.
• Analyze quality data to identify trends and CAPAs.
• Apply DOE and data analysis to optimize products and processes.
• Provide SME guidance across product development, pilot, manufacturing, and supplier networks.
• Mentor junior staff and support BD reliability engineering initiatives.

Skills

Quality Engineering

Design Controls

Risk Management

Statistical Methods

DOE

Gage R&R

CAPA

FDA QSR

ISO13485

Education

BS in Engineering

MS in Engineering

Job description

We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Responsibilities

• Provide technical leadership and guidance to Quality Engineers, Quality Technicians, and Inspectors.
• Lead and support quality engineering projects that enhance quality systems, procedures, and compliance processes.
• Develop test protocols and final reports to support regulatory submissions, including FDA510(k), PMA, CE Mark, and international product registrations.
• Support early‑stage product innovation activities by contributing quality expertise during pre‑concept and front‑end development of new technologies.
• Develop and maintain Risk Management Files, coordinating input across cross‑functional design teams.
• Participate in the creation and execution of Design Verification and Design Validation protocols, analyze results, and determine overall design acceptability.
• Contribute to project Trace Matrices, Product Performance Specifications, Product Development Plans, and other design control documentation in accordance with the BD UCC product development process.
• Coordinate and document external laboratory testing activities, including cleaning and reprocessing validations.
• Develop and improve inspection and test methods aligned with product specifications.
• Support shelf‑life and stability studies by developing test protocols and final reports used to establish expiration dating.
• Perform test method validations to ensure analytical and physical testing methods are accurate, precise, reliable, and reproducible.
• Create and maintain inspection plans for components, subassemblies, and finished products.
• Support the development of manufacturing control plans for both internal and outsourced manufacturing processes.
• Lead or support risk management activities, including AFMEA, DFMEA, and PFMEA development.
• Conduct and support process development studies to evaluate new manufacturing processes and equipment.
• Design, qualify, and validate inspection methods, testing equipment, and measurement systems.
• Provide quality engineering support to outsourced laboratories and manufacturing partners, ensuring compliance with 21CFR820, 210, 211, cGMP, and ISO13485 requirements.
• Lead supplier qualification activities, including component qualification, mold validation, and Design of Experiments (DOE).
• Support process transfers and scale‑up activities into production environments.
• Review and disposition nonconforming materials and products.
• Analyze quality data and generate reports to identify trends, monitor process performance, and assess the effectiveness of process improvements and CAPAs.
• Develop and implement corrective and preventive action plans to address nonconformances and drive continuous improvement.
• Apply statistical methods, including DOE and data analysis techniques, to optimize products and processes and identify root causes of variation.
• Provide technical expertise to resolve quality issues across product development, pilot production, manufacturing operations, and supplier networks.
• Support departmental and organizational quality objectives through collaboration and continuous improvement initiatives.
• Mentor and develop junior team members, fostering technical growth and quality excellence.
• Serve as the Business Unit Subject Matter Expert (SME) for Reliability Engineering.
• Perform additional quality control and quality engineering initiatives as assigned by Quality leadership.

Required Qualifications

• B.S. and 8 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving ORM.
• S. and 6 years experience in Quality Engineering discipline including design controls, product/process validation, risk management, and technical problem solving.

Ability to Travel

Knowledge and Skills

• A high level of competence in Quality Technology, statistical techniques, and six sigma tools including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.
• Strong Design Control understanding from concept to launch; including in post‑market activities (including complaints, failure investigations, and CAPAs).
• Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001.

At BD, we prioritize on‑site collaboration because we believe it fosters creativity, innovation, and effective problem‑solving, which are essential in the fast‑paced healthcare industry. For most roles, we require a minimum of 4 days of in‑office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work‑life balance. Remote or field‑based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID‑19. In some locations, testing for COVID‑19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

#CLOLIWhy Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers .

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required SkillsOptional Skills.

Primary Work LocationUSA GA - Covington BMDAdditional LocationsWork Shift