Staff Design Quality Engineer

BD; Covington (GA); On-site; USD 115,000 - 160,000; Full time

Job summary

BD is seeking a senior Quality Engineer to provide technical leadership across quality teams and guide regulatory submissions. You will drive design controls, risk management, and process validation to ensure compliance with 21 CFR 820, ISO 13485, and related standards.

Role requires strong expertise in QA methodologies, data analysis, and cross-functional collaboration to support manufacturing and supplier networks. This position is based in Covington, GA with on-site requirements.

Qualifications

• BS with 8+ years in quality engineering; design controls, validation, risk management, problem solving.
• MS with 6+ years in quality engineering; design controls, validation, and regulatory knowledge.

Responsibilities

• Provide technical leadership toQuality Engineers,Technicians, and Inspectors.
• Lead quality projects to improve systems, procedures, and compliance.
• Develop test protocols and reports for FDA/CE submissions.
• Support pre-concept and front-end development with quality expertise.
• Develop and maintain Risk Management Files across cross-functional teams.
• Create and execute Design Verification/Validation protocols and analyses.

Skills

Quality Engineering

Design Controls

Statistical Methods

Six Sigma

FDA QSR

ISO 13485

ISO 9001

Process Validation

Education

Bachelor's degree in a related field

Master's degree in related field

Tools

None

Job description

We are the people who give possibilities purpose

BD 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 FDA 510(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 21 CFR 820, 210, 211, cGMP, and ISO 13485 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 OR
• M.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.

Why 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.

Primary Work Location

USA GA - Covington BMD