Sr. Quality Engineer

BD; Covington (FL); Presencial; USD 75.000 - 95.000; Jornada completa

Descripción de la vacante

BD is a leading global medical technology company seeking a Quality Engineer to develop and maintain quality plans, ensuring FDA QSR and ISO 13485 compliance throughout the product lifecycle at the Covington, GA site.

You will lead design controls, risk assessments, CAPA, audits, supplier quality, and data-driven improvement, collaborating with R&D, Manufacturing, Regulatory Affairs and other functions. A Bachelor's in Engineering and 3 years of medical device quality experience are required.

Formación

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

Responsabilidades

• Develop, implement, and maintain quality plans, procedures, and specs to ensure FDA QSR/ISO 13485 compliance.
• Support product development through design controls, risk assessments, and verification/validation testing.
• Investigate nonconformances, customer complaints, and deviations using root cause analysis and CAPA.
• Plan and execute internal and external audits to evaluate quality system compliance.
• Partner with suppliers on qualification, performance monitoring, and supplier quality management.
• Analyze quality metrics, prepare reports, and communicate insights to leadership.
• Lead continuous improvement initiatives using Lean, Six Sigma, and other quality tools.
• Deliver training and guidance on quality systems and compliance to cross-functional teams.
• Collaborate with R&D, Manufacturing, Regulatory Affairs to embed quality across the product lifecycle.
• Support regulatory submissions and respond to inquiries as needed.

Conocimientos

FDA QSR compliance

ISO 13485

CAPA process

Design controls

Risk management ISO 14971

Minitab

SPC

FMEA

Statistical analysis

Cross-functional collaboration

Educación

Bachelor's degree in Chemical Engineering or related engineering

Herramientas

Minitab

SPC

FMEA

Descripción del empleo

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.

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Primary Work Location

USA GA - Covington BMD

Work Shift

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