Sr. Quality Engineer

Becton, Dickinson and Company; Covington (GA); On-site; USD 80,000 - 110,000; Full time

Job summary

Becton, Dickinson and Company in Covington, GA is seeking a Quality Engineer to develop, implement, and maintain quality plans ensuring compliance with FDA QSR and ISO 13485.

You will lead design control activities, perform risk assessments, CAPA, audits, and supplier quality management, and work with R&D, Regulatory Affairs, and Manufacturing to embed quality throughout the product lifecycle in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in Chemical Engineering or related field.
• 3 years of experience in a Quality Engineering role within the medical device industry.
• Experience with design controls, ISO 14971 risk management, and CAPA processes.

Responsibilities

• Develop and maintain quality plans, procedures, and specifications to meet FDA QSR and ISO 13485.
• Support product development through design control activities incl. design reviews and risk assessments.
• Investigate nonconformances, complaints, and deviations; drive CAPA.
• Plan and execute audits; improve quality system and supplier quality.
• Lead continuous improvement with Lean, Six Sigma; train cross-functional teams.
• Collaborate with R&D, Manufacturing, Regulatory, and others to embed quality throughout the product lifecycle.
• Support regulatory submissions and respond to inquiries as needed.

Skills

QSR compliance

CAPA processes

Statistical methods

Root cause analysis

Education

Bachelor's in Chemical Engineering

Tools

Minitab

SPC

FMEA

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

Job Responsibilities: Develop, implement, and maintain quality plans, procedures, and specifications to ensure compliance with regulatory requirements and industry standards, including FDA QSR and ISO 13485. Support product development through design control activities such as design reviews, risk assessments, and verification and validation testing to ensure product quality, safety, and effectiveness. Investigate product nonconformances, customer complaints, and manufacturing deviations using root cause analysis methodologies, and drive effective Corrective and Preventive Actions (CAPA). Plan and execute internal and external audits to evaluate quality system compliance and identify opportunities for continuous improvement. Partner with suppliers to support qualification, performance monitoring, and ongoing supplier quality management activities. Analyze quality metrics and trends, prepare reports, and communicate quality performance insights to leadership and key stakeholders. Lead and contribute to continuous improvement initiatives utilizing Lean, Six Sigma, and other quality tools and methodologies. Deliver training, coaching, and guidance to cross-functional teams on quality systems, compliance requirements, and best practices. Collaborate closely with R&D, Manufacturing, Regulatory Affairs, and other business functions to embed quality throughout the entire product lifecycle. Support regulatory submissions and assist in responding to regulatory agency inquiries as needed.

Required Qualifications

Bachelor's degree in Chemical Engineering or a closely related engineering disciplines 3 years of experience in a Quality Engineering role within the medical device industry. Demonstrated experience with design controls, risk management (ISO 14971), and CAPA processes.

Skills and Knowledge

Demonstrated knowledge of chemical processes, materials, process validation, manufacturing operations, and continuous improvement methodologies. Strong understanding of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485. Proficiency in statistical analysis techniques and quality tools (e.g., Minitab, SPC, FMEA). Excellent problem-solving, analytical, and critical thinking skills. Strong written and verbal communication skills, with the ability to effectively interact with all levels of the organization. Ability to work independently and as part of a cross-functional team in a fast-paced environment.

Preferred Qualifications

ASQ certifications (e.g., CQE, CSSBB) Experience with Class II or III devices

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

Additional Locations Work Shift US BD 1st Shift 8am-5pm (United States of America)

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.