Quality Assurance Manager

Quality Assurance Manager – BD Nogales Norte

The Quality Assurance Manager is responsible for strategic oversight and leadership direction within the Production QA function. Duties include In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, and Supplier Quality while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), international standards (ISO 13485, MHRA GMPs, etc.), and BD policies/procedures. The Associate provides business, technical, and production support as required, offers technical guidance to employees, develops processes and procedures, and has in-depth Quality Assurance expertise.

• Effective implementation of the site Quality Management System (QMS)
• Strategic oversight and leadership of In‑Coming Inspection, In‑Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation and Supplier Quality
• Knowledge of FDA regulatory requirements (QSRs – 21 CFR Part 820)
• Knowledge of international regulatory requirements (ISO 13845, MHRA GMPs, etc.)
• Responsible for Production and Process Controls from a Quality perspective
• Serve as a technical resource for all QA activities
• Identify data requirements beyond the standard and collect relevant data to analyze complex problems
• Advise others on a variety of topics within the QA functional area
• Track internal trends and suggest process improvements based on observations
• Leverage appropriate resources to provide solutions for internal/external customers
• Apply hypotheses and an understanding of cause and effect when analyzing complex processes or data patterns
• Identify implications and conclusions from the logical analysis of complex situations
• Serve as the QA subject matter expert for internal/external regulatory compliance audits
• Drive the team to achieve established goals proactively and pragmatically; adjust plans to overcome obstacles and achieve success
• Manage budget for the area, allocate resources, and delegate accordingly, applying knowledge of profit drivers within the department

• Bachelor of Science degree in engineering or a related field
• Minimum 7 years of quality experience, with at least 3–5 years in the medical device or pharmaceutical industry
• Minimum 2–3 years of management experience
• Experience interfacing with domestic and foreign government agencies (including audit management and front‑room experience)
• Experience with CAPAs and validation

• Experience with SAP
• Lean/Six Sigma experience
• Computer proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook)

• Must be able to lift, push/pull, and carry up to 25 pounds
• Must wear appropriate personal protective equipment as required
• Position requires sitting or standing for long hours
• Use of hands and fingers to manipulate office and calibration equipment is required

BD is one of the world’s largest medical technology companies, dedicated to advancing health and creating transformative solutions. We value each team member’s unique contributions and encourage growth, collaboration, and accountability. Join us to learn, innovate, and make a tangible impact on global health.

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 status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.