BD Nogales Norte
Quality Systems & Regulatory Staff Lead
BD Nogales Norte, San Diego, California, United States, 92189
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The Quality Systems and Regulatory Staff Lead ensures robust governance and execution of post‑market quality processes, including CAPA management, issue impact determinations, field action decisions and follow‑ups. The role evaluates quality signals to determine escalation, aligns investigations and corrective actions with regulatory requirements, and partners cross‑functionally to scope field actions. It collaborates and provides feedback on the Post‑Market Risk Assessment and Health Hazard Evaluation (HHE) process, drives continuous improvement across the quality system, and leverages analytics to monitor KPIs, identify systemic issues, and implement timely solutions that uphold product safety, compliance, and customer trust.
Key Responsibilities
Support development, execution, and governance of remediation and prevention strategies as well as post‑market issue impact/risk assessments. Evaluate potential issues before formal CAPA initiation; conduct structured evaluations of quality signals, complaints, audit findings, and other inputs to determine whether formal CAPA is warranted. Confirm that CAPA investigations are directly tied to the reason for the recall and that corrective and preventive actions are appropriate and effective. Support comprehensive issue impact and risk evaluations, apply risk‑based methods to prioritize actions, and facilitate discussions with relevant functions. Ensure HRA or HHE alignment by collaborating with cross‑functional teams to determine scope of field actions. Draft and coordinate responses to FDA warning letters, field action inquiries, and other regulatory correspondence. Drive end‑to‑end process improvements throughout the quality system. Leverage data analytics to uncover opportunities for benchmark and KPI refinements, monitor performance indicators, and propose targeted improvements. Background and Experience
Bachelor’s Degree in Engineering, Life Sciences, or a related technical discipline. Minimum 7 years of progressive experience in medical device Quality Assurance. Minimum 5 years of hands‑on risk management experience, including ISO 14971. Experience communicating directly with FDA, including drafting regulatory responses. Comprehensive knowledge of ISO 13485, ISO 9001, 21 CFR Part 820, EU MDR. Proven leadership capabilities, driving cross‑functional collaboration and quality initiatives. Strong analytical, problem‑solving, and decision‑making skills with ability to manage multiple priorities. Primary Work Location: USA, CA – San Diego, TC Bldg C&D Salary range: $155,900.00 – $257,300.00 USD Annual Becton, Dickinson & 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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Support development, execution, and governance of remediation and prevention strategies as well as post‑market issue impact/risk assessments. Evaluate potential issues before formal CAPA initiation; conduct structured evaluations of quality signals, complaints, audit findings, and other inputs to determine whether formal CAPA is warranted. Confirm that CAPA investigations are directly tied to the reason for the recall and that corrective and preventive actions are appropriate and effective. Support comprehensive issue impact and risk evaluations, apply risk‑based methods to prioritize actions, and facilitate discussions with relevant functions. Ensure HRA or HHE alignment by collaborating with cross‑functional teams to determine scope of field actions. Draft and coordinate responses to FDA warning letters, field action inquiries, and other regulatory correspondence. Drive end‑to‑end process improvements throughout the quality system. Leverage data analytics to uncover opportunities for benchmark and KPI refinements, monitor performance indicators, and propose targeted improvements. Background and Experience
Bachelor’s Degree in Engineering, Life Sciences, or a related technical discipline. Minimum 7 years of progressive experience in medical device Quality Assurance. Minimum 5 years of hands‑on risk management experience, including ISO 14971. Experience communicating directly with FDA, including drafting regulatory responses. Comprehensive knowledge of ISO 13485, ISO 9001, 21 CFR Part 820, EU MDR. Proven leadership capabilities, driving cross‑functional collaboration and quality initiatives. Strong analytical, problem‑solving, and decision‑making skills with ability to manage multiple priorities. Primary Work Location: USA, CA – San Diego, TC Bldg C&D Salary range: $155,900.00 – $257,300.00 USD Annual Becton, Dickinson & 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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