BD Nogales Norte
Job Description Summary
This role supports the entire product complaint process, ensuring compliance with global regulations such as FDA cGMP and ISO standards. The incumbent will lead, trend, and approve customer complaint investigations, act as the subject?matter expert during audits, and collaborate cross?functionally with Quality Assurance, Regulatory Affairs, Manufacturing, and Patient Safety. Responsibilities Process Oversight: Direct and manage the complaint processing team, ensuring all complaints are handled per SOPs and regulatory requirements. Investigation Management: Oversee and conduct product complaint investigations, gather information, coordinate sample returns for evaluation, and determine root causes. Regulatory Reporting: Assess complaints to determine if they are reportable events (e.g., adverse events, medical device reports) and ensure timely submission to regulatory agencies such as the FDA. Documentation and Record Keeping: Ensure accurate and detailed records of all complaint investigations and resolutions are maintained in the Quality Management System database. Trending and Analysis: Perform analysis and trending of complaint data to identify recurring issues, potential risks, and areas for continuous improvement. Cross?functional Collaboration: Partner with internal departments (R&D, Manufacturing, Supply Chain, etc.) and external contract manufacturing organizations to address and resolve complex issues. Audits and Inspections: Serve as the subject?matter expert for the complaint process during internal and external audits and regulatory inspections. Team Leadership & Mentorship: Coach, train, and mentor team members on complaint handling processes and procedures, fostering a culture of compliance and excellence. Continuous Improvement: Identify areas for process improvement and lead initiatives or participate in CAPA activities related to complaint findings.
Minimum Requirements
Education: Bachelors degree required (preferably within the Sciences, Engineering, or Clinical fields). Experience: 24 years of complaint handling, post?market surveillance, or quality system experience in the medical device industry (required). Experience in pharma is preferred. Previous experience conducting or leading root?cause investigations. Demonstrated leadership and communication skills with strong attention to detail.
Preferred Qualifications
Advanced degree in a scientific or related discipline. Pharma industry experience. Previous experience presenting during internal or external audits.
Company Overview
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our purpose, and its no small feat. We bring together design, engineering, manufacturing, and marketing to transform ideas into solutions that improve patients lives. Why Join Us?
An environment that supports learning, growth, and your best self. Youll become a maker of possible with BD. Equal Opportunity Employer 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 or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Contact & Next Steps
To learn more about BD visit https://bd.com/careers. #J-18808-Ljbffr
This role supports the entire product complaint process, ensuring compliance with global regulations such as FDA cGMP and ISO standards. The incumbent will lead, trend, and approve customer complaint investigations, act as the subject?matter expert during audits, and collaborate cross?functionally with Quality Assurance, Regulatory Affairs, Manufacturing, and Patient Safety. Responsibilities Process Oversight: Direct and manage the complaint processing team, ensuring all complaints are handled per SOPs and regulatory requirements. Investigation Management: Oversee and conduct product complaint investigations, gather information, coordinate sample returns for evaluation, and determine root causes. Regulatory Reporting: Assess complaints to determine if they are reportable events (e.g., adverse events, medical device reports) and ensure timely submission to regulatory agencies such as the FDA. Documentation and Record Keeping: Ensure accurate and detailed records of all complaint investigations and resolutions are maintained in the Quality Management System database. Trending and Analysis: Perform analysis and trending of complaint data to identify recurring issues, potential risks, and areas for continuous improvement. Cross?functional Collaboration: Partner with internal departments (R&D, Manufacturing, Supply Chain, etc.) and external contract manufacturing organizations to address and resolve complex issues. Audits and Inspections: Serve as the subject?matter expert for the complaint process during internal and external audits and regulatory inspections. Team Leadership & Mentorship: Coach, train, and mentor team members on complaint handling processes and procedures, fostering a culture of compliance and excellence. Continuous Improvement: Identify areas for process improvement and lead initiatives or participate in CAPA activities related to complaint findings.
Minimum Requirements
Education: Bachelors degree required (preferably within the Sciences, Engineering, or Clinical fields). Experience: 24 years of complaint handling, post?market surveillance, or quality system experience in the medical device industry (required). Experience in pharma is preferred. Previous experience conducting or leading root?cause investigations. Demonstrated leadership and communication skills with strong attention to detail.
Preferred Qualifications
Advanced degree in a scientific or related discipline. Pharma industry experience. Previous experience presenting during internal or external audits.
Company Overview
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our purpose, and its no small feat. We bring together design, engineering, manufacturing, and marketing to transform ideas into solutions that improve patients lives. Why Join Us?
An environment that supports learning, growth, and your best self. Youll become a maker of possible with BD. Equal Opportunity Employer 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 or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Contact & Next Steps
To learn more about BD visit https://bd.com/careers. #J-18808-Ljbffr