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Jobs or company...

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

Salary undisclosed
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Job Description SummaryJob DescriptionWe are the makers of possibleBD 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.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.Become a maker of possible with us!Job SummaryThis position is responsible for performance of audits in support of the BD Quality Audit program. In this role, you are responsible for carrying out quality audits to support the various audit programs impacting BD sites.In addition, you will work with the sites to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures. Maintain the audit database to monitor audit program metrics and prepare reports for management.Job Responsibilities
  • 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.
Preferred Requirements
  • 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 Skills required:
  • 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 Environment:
  • 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.
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:Required SkillsOptional Skills.Primary Work Location SGP The StrategyAdditional LocationsWork Shift
Job Description SummaryJob DescriptionWe are the makers of possibleBD 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.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.Become a maker of possible with us!Job SummaryThis position is responsible for performance of audits in support of the BD Quality Audit program. In this role, you are responsible for carrying out quality audits to support the various audit programs impacting BD sites.In addition, you will work with the sites to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures. Maintain the audit database to monitor audit program metrics and prepare reports for management.Job Responsibilities
  • 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.
Preferred Requirements
  • 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 Skills required:
  • 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 Environment:
  • 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.
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:Required SkillsOptional Skills.Primary Work Location SGP The StrategyAdditional LocationsWork Shift