BD Nogales Norte
Quality Assurance Manager – BD Nogales Norte
Job Description Summary 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.
Responsibilities
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
Minimum Requirements
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
Preferred Requirements
Experience with SAP
Lean/Six Sigma experience
Computer proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook)
Physical Demands
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
Why Join Us? 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.
Equal Opportunity Statement 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.
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Job Description Summary 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.
Responsibilities
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
Minimum Requirements
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
Preferred Requirements
Experience with SAP
Lean/Six Sigma experience
Computer proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook)
Physical Demands
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
Why Join Us? 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.
Equal Opportunity Statement 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.
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