Job Description Summary
This position is responsible for performance of audits in support of the BD Quality Audit program. In this role, he/she is responsible for carrying out quality audits to support the various audit programs impacting BD sites. In addition, he/she will work with the sites to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures. He/she will maintain the audit database to monitor audit program metrics and prepare reports for management.
Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
About the role As Staff Quality Auditor I, you will be responsible for the performance of audits in support of the BD Quality Audit program in the EMEA region and others as directed by the Associate Director, Quality & Regulatory Compliance, Quality Audits.
Main responsibilities will include: Conducts Quality Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures. Follows up with the auditee as required to compile information relating to the audits. Evaluates the adequacy of the provided evidence against the approved Audit Action Plan (AAP). Maintains the audit system software database to record the status of all audits and associated actions. Provides periodic reports to management based on the audit statuses and defined metrics. Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate. This individual's primary responsibility will be to perform quality internal audits of the various location's Quality management systems. This individual will also be responsible for the execution of the department's projects and strategic initiatives. This individual will be interacting with individuals at various levels of the organization across multiple sites in performing audits at these assigned locations including top management. About you B.S. Engineering, Chemistry, Biology or equivalent discipline, advanced degree is preferred. One of the below certifications or equivalent: (Required) Certified Quality Auditor/ISO Lead Auditor Certified Certified Quality Engineer Certified Manager of Quality / Organizational Excellence Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation) Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred) Minimum 8-10 years of work experience in the quality organization of a medical device and/or pharmaceutical company. Minimum of 5+ years' experience in auditing compliance with domestic and international regulations for medical devices or pharmaceuticals. Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. To learn more about BD visit: https://bd.com/careers Primary Work Location GBR Winnersh - Eskdale Road Additional Locations BEL Erembodegem - Dorp 86, BEL Olen, BEL Temse - Laagstraat, ESP Almaraz - Ctra. Nacional, ESP Barcelona, ESP Huesca - Fraga, ESP Malaga - Camino de Casabermeja, ESP Salamanca, ESP San Agustin del Guadalix, ESP Valencia - Paterna, ESP Zaragoza, GBR Crawley, GBR Leeds, GBR Plymouth - Belliver Industrial Estate, GBR Swindon - Dorcan, GBR Worthing
#J-18808-Ljbffr
Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
About the role As Staff Quality Auditor I, you will be responsible for the performance of audits in support of the BD Quality Audit program in the EMEA region and others as directed by the Associate Director, Quality & Regulatory Compliance, Quality Audits.
Main responsibilities will include: Conducts Quality Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures. Follows up with the auditee as required to compile information relating to the audits. Evaluates the adequacy of the provided evidence against the approved Audit Action Plan (AAP). Maintains the audit system software database to record the status of all audits and associated actions. Provides periodic reports to management based on the audit statuses and defined metrics. Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate. This individual's primary responsibility will be to perform quality internal audits of the various location's Quality management systems. This individual will also be responsible for the execution of the department's projects and strategic initiatives. This individual will be interacting with individuals at various levels of the organization across multiple sites in performing audits at these assigned locations including top management. About you B.S. Engineering, Chemistry, Biology or equivalent discipline, advanced degree is preferred. One of the below certifications or equivalent: (Required) Certified Quality Auditor/ISO Lead Auditor Certified Certified Quality Engineer Certified Manager of Quality / Organizational Excellence Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation) Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred) Minimum 8-10 years of work experience in the quality organization of a medical device and/or pharmaceutical company. Minimum of 5+ years' experience in auditing compliance with domestic and international regulations for medical devices or pharmaceuticals. Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. To learn more about BD visit: https://bd.com/careers Primary Work Location GBR Winnersh - Eskdale Road Additional Locations BEL Erembodegem - Dorp 86, BEL Olen, BEL Temse - Laagstraat, ESP Almaraz - Ctra. Nacional, ESP Barcelona, ESP Huesca - Fraga, ESP Malaga - Camino de Casabermeja, ESP Salamanca, ESP San Agustin del Guadalix, ESP Valencia - Paterna, ESP Zaragoza, GBR Crawley, GBR Leeds, GBR Plymouth - Belliver Industrial Estate, GBR Swindon - Dorcan, GBR Worthing
#J-18808-Ljbffr
