BD (Becton, Dickinson and Company) Internal Quality Auditor EMEA in Community Of Madrid, Spain
Job Description Summary
The Staff Quality Auditor I is responsible for performance of audits in support of the BD Corporate Quality Internal Audit program. In this role, he/she is responsible for carrying out audits under the direction of the Director, Corporate Quality Audit within Europe. 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.
Staff Quality Auditor I
A superb, wide-ranging Staff Quality Auditor career development role with BD, a global leader in Medical Technology.
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to ‘helping all people live healthy lives’.
The Internal Quality Auditor is responsible for performance of audits in support of the BD Corporate Quality Internal Audit program within Europe. In this role, he/she is responsible for carrying out audits under the direction of the Senior Manager and/or Assoc. Director Corporate Internal Audit. 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.
Primary Responsibilities and Duties
Conduct Corporate Quality Internal Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.
Follow 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
Maintain the audit system software database to record the status of all audits and associated actions.
Provide 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.
May perform other duties as required
Education & Experience Requirements
Extensive knowledge and ability to apply international regulations and standards of FDA QSR, ISO 13485, EU MDR/IVDR, and ISO 14971 standards.
Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; MDSAP; Sterilization (EtO, Irradiation)
Excellent verbal and written communication skills required
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
Bachelor’s degree in Engineering, Chemistry, Biology, or other related discipline
Must have one of the following certifications or equivalent from an accredited organization: Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, or Certified Quality Manager
A minimum of 5 years work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
A minimum of 3 years’ experience in auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.
Experience using electronic QMS (e.g. Trackwise) preferred
Fluent level of English (any other European language is a plus)
Requires 30-50% domestic and international travel
Must be able to enter Laboratory and Manufacturing environments that may have specific PPE and health requirements.
It’s a superb, all-round Staff Quality Auditor I career development role with a world leader in medical devices. So if this describes you and your aspirations, then please click on the APPLY button.
Primary Work Location
ESP San Agustin del Guadalix
ITA Milano - Via Enrico Cialdini, PRT Lisbon - Carcavelos
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.