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.

　　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

　　The Sr. Specialist, Post Market Quality position reports directly to the Sr. Manager, Post Market Quality, Field Action Operations. The Sr. Specialist, Post Market Quality position is responsible for working with all sites worldwide on various post market quality issues, including,

　　Supporting timely execution of field actions within North America (US and Canada).

　　Aligning and coordinating with Regional PMQ Representatives from EMEA, Latin America and Greater Asia to ensure alignment of field action execution.

　　Submission of monthly status reports to US and Canadian Regulatory Bodies.

　　Supporting timely Field Action Committee (FAC) meetings.

　　Ensuring field action documentation (customer letter, 806 report, etc.) is created/maintained.

　　Primary Duties (essential functions) include, but are not limited to :

　　Performs Global Regulatory Impact Assessment (GRIA) for North America and serves as coordinator to all other regions/countries for GRIA completion maintaining all regional documentation in the field action file

　　Assists in preparation of distribution reports as needed for field action preparation

　　Prepares FDA monthly reports in support of 21CFR 806 field action requirements

　　Maintains the “official record” field action file, ensuring all documentation is complete and appropriately filed in accordance with department standards to facilitate easy retrieval for audit support

　　Prepares FDA request for termination documentation to include any product reconciliation required in the final destruction of affected product

　　Tracks recall activities to closure and prepares the final closure documentation for each field action file

　　Compiles field action data in support of BU Management Reviews

　　Ensures all SharePoint data is complete for metric reporting

　　Provides documents in support of BDX-wide audits as needed

　　Handles data requests from other departments for field action activities

　　Participates in post market surveillance data review meetings as needed in support of field action activities

　　Serve as a team member and/or leader on projects for the department as assigned

　　Supports revisions to policies and procedures related to the field action process as needed

　　Participates in the development, review, issuance and training of BD policies and procedures related to Post Market Quality

　　Develops solutions to routine assigned activities of moderate scope and complexity

　　This position has no direct reports and must accomplish tasks through cooperation with other Regulatory, Quality, Medical, Operations, and R&D professionals worldwide.

　　Required Qualifications

　　BA or BS degree, with minimum of 5 years relevant experience in the medical device, in vitro diagnostics, or pharmaceutical industry.

　　Working knowledge of 21 CFR820, ISO 13485, and other international standards as required

　　Ability to support business needs for Pacific Standard Time (PST).

　　Proficiency in Microsoft Office, specifically Word and Excel

　　Must be able to work optimally across business units, regions, and manufacturing sites

　　Excellent written and oral communication skills

　　Strong organization and prioritization skills

　　Preferred Qualifications

　　Experience with post market surveillance and/or post market quality.

　　Expertise in participating in both internal and external audits.

　　Experience in 21CFR 806 and Canada Recall Regulations.

　　Experience with medical devices containing software.

　　Experience working within software management systems, such as, ERP and QMS systems.

　　The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

　　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.

　　PDN

　　Primary Work Location

　　USA TX - San Antonio

　　Additional Locations

　　USA AZ - Tempe Headquarters, USA GA - Covington BMD, USA IL - Vernon Hills, USA MD - Sparks - 7 Loveton Circle, USA NJ - Franklin Lakes, USA RI - Warwick

　　Work Shift

　　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.