Sr. Quality Chemical Engineer

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

Additional information

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.

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