Quality Audit & Compliance Specialist (Auditor)

This position is responsible for the 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., In our Quality team, we collaborate on a large scale, focusing on making sure everything is correct, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients., As a Quality Audit & Compliance Specialist (Auditor) 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. 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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self.,

• Conducts Quality Audits to ensure 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.
• Evaluate the adequacy of the provided evidence against the approved Audit Action Plan (AAP). In conjunction with management, develop plans to address inadequate AAP documentation when required.
• 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 of 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 locations' Quality management systems, which may result in the identification of compliance risks that need to be addressed by the business to improve its compliance position and influence the quality strategy by the management team.
• This individual will also be responsible for executing the department's projects and strategic initiatives.
• This individual will interact with individuals at various levels of the organization across multiple sites when performing audits at these assigned locations, including top management.
  
  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
• Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred)
• Minimum 3 years of work experience in the quality organization of a medical device and/or pharmaceutical company. Experience with warning letters and other regulatory actions is preferred.
• Experience in auditing compliance with domestic and international medical device or pharmaceutical regulations.
• Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation), Ambitious
• Collaborative
• Goal-oriented
• Persuasive
• Results-driven
• Self-starter
  
  Be part of something bigger at BD. Here, you'll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You'll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it's the right thing to do, but because our products impact people's quality of life. Here, you'll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health . At BD, you can make a true difference of one., 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., To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place., Advancing the world of health
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve. Eric Rainis, To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.