Summary

BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.

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 discipline
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

Requirements

Bachelor's degree in Chemical Engineering or a closely related engineering discipline
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
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
Ability to work independently and as part of a cross-functional team
ASQ certifications (e.g., CQE, CSSBB)
Experience with Class II or III devices

Benefits

On-site collaboration
4 days in-office per week
Flexibility and work-life balance

Company overview

BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.