Sr. Quality Engineer - Product Development

Overview

Senior Design Quality Engineer – responsible for ensuring quality and patient safety across the product lifecycle for BD's critical medical devices. Works at the intersection of innovation and compliance to maintain high standards and protect business risk.

• Serve as QA expert for entire product line, owning Design Control, Document Control, and QA processes from concept to commercialization.
• Collaborate with contract manufacturers and internal plants to implement changes and uphold quality standards.
• Monitor complaint trends, proactively identify performance drift, and execute corrective actions.
• Act as subject‑matter authority for cross‑functional teams in Engineering, Operations, and supplier management.
• Represent QA on project teams and ensure Design Control principles are integrated into product and process changes and new product development.
• Lead QA initiatives, build, review, and approve critical documents such as CAPAs, audit reports, Design History Files.
• Develop, review, and approve validation protocols for processes, products, stability studies, and software.
• Create risk assessments using FMEA, FMECA, and FTA methodologies.
• Mentor staff, supervise technicians and engineers, and develop future quality leaders.
• Implement corrective and preventive action plans to improve processes and products.
• Conduct internal and supplier quality system audits across the supply chain.
• Maintain active membership in trade and professional organizations and bring new standards to the team.
• Investigate complaints, identify root causes, and track quality metrics.
• Collaborate with manufacturing sites to ensure quality consistency.
• Serve as independent QA reviewer and chair of design reviews.

• Bachelor’s degree in Engineering with 4+ years of Quality Engineering experience in a regulated environment, or Master’s degree with 2+ years of Quality Engineering experience.
• Strong questioning and problem‑solving skills.
• Detail‑oriented with ability to organize large amounts of work and data; proficient in documentation practices.
• Knowledge of regulatory requirements including FDA, MDSAP, PMDA, CFDA and IEC
  60601 standards.
• Experience working with international suppliers/manufacturers on product quality and reliability.
• Experience interpreting regulations and procedures accurately.
• Statistical analysis knowledge and applied statistical methods.

• Experience with electro‑mechanical capital systems.
• ASQ certification.

Primary work location:
Covington, GA. Minimum 4 days per week in‑office. Remote or field‑based positions may have different arrangements. Employment is contingent upon proof of full vaccination against COVID‑19, as required by the Company.

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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