Sr. Quality Engineer

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 Med Tech 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 disciplines3 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…