Staff Quality Auditor, Greater Asia (Quality & Regulatory Compliance)

Job Description Summary

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.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

• 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). 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 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 which may result in 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 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.

• Bachelor Degree in Engineering, Chemistry, Biology or equivalent discipline is preferred.
• Mandatory to have one of the certifications or equivalent: Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer or Certified Manager of Quality /Organizational Excellence.
• Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred)
• Minimum 10 years of experience work experience in the Quality organization of a Medical Device and/or pharmaceutical company. Experience with warning letters and other regulatory actions preferred.
• Minimum of 5+ years' experience in with auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.

• Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation)
• Knowledge of other international medical device regulations preferred (e.g., US, China, Singapore, Korea, etc.)
• Excellent verbal and written communication skills
• Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical.
• Strong analytical skills
• Effective project management and organizational skills are essential.

• Work in an office setting and be physically able to travel domestically and internationally (Travel is 40-60%).
• As part of a quality audit, must be able to enter Laboratory and Manufacturing environments that may have specific PPE and health requirements.