The Staff Quality System Specialist I is accountable for support of the continued development, improvement, and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions, and project teams for project teams for process improvement and continuous improvement activities.
Job Description
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. Become a maker of possible with us.
Summary of Position
The Internal Audit Program Manager is accountable for support of the continued development, improvement, and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions, and project teams for project teams for process improvement and continuous improvement activities.
Responsibilities
Management of the internal audit program, ensuring adherence to applicable regulatory requirements, including but not limited to, ISO 13485, CFR 820, MDSAP, MDD/MDR, and IVD/IVDR. The successful candidate will facilitate, and host external audits conducted by government agencies, notified bodies, auditing organizations, and customers.
Responsible for reviewing non-conformances (NCs) and CAPA records in accordance with the quality system procedures. This includes supporting the quality team to carry out NC investigations, follow up on CAPA implementation, review of corrective action reports (CARs), verification of the effectiveness of corrective actions, support in preparation of periodic management reviews, and execution of internal audits.
Ensure compliance with global requirements through interpretation of standards such as ISO13485; ISO14971 ; etc.
Assess product and process changes using risk analysis tools, including FMEAs, and prepare documentation as needed.
Support customer complaint investigations and recalls.
Maintain knowledge of regulatory requirements through interaction with local regulatory authorities, attendance at industry conferences, and participation in professional organizations.
May perform other duties as assigned.
Requirements
Education
Bachelor's degree in engineering or science preferred
Experience
At least five years experience in Quality Systems/Auditing function, preferably in medical device .
Expert knowledge of ISO 13485, ISO14971, (EU) 2017/745, (EU) 2017/746, RDC 665/2022, TGA regulation 2002, 21 CFR 820 and SOR/98-282.
Proven experience in managing non-conformance investigations, root cause analysis, and CAPA implementation.
Experience in preparing for and conducting internal audits.
Proficiency in risk analysis, failure investigations, and problem-solving.
Skills
Ability to apply statistical concepts and techniques to data analysis
Proficiency in Microsoft Office software suite, including Word, Excel, PowerPoint, Outlook, Teams, Sharepoint
Strong written and verbal communication skills
Able to work independently, manage multiple tasks simultaneously, and meet deadlines
Travel
10% domestic and possibly international as well
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required . Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
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.
To learn more about BD visit https://bd.com/careers
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.
