Distribution Associate

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.

Responsible for the Internal Quality Audits system; including but not limited to:

• Prepare Internal Quality Audit Schedule

• Performing audits of products and quality systems

• Support hosting external audits and inspections

• Maintenance of compliance metrics

• Ensure all internal audit activities are completed on a timely manner

Supports the Senior Quality Manager and the Quality / Auditing System Manager in the identification and resolution of quality assurance and regulatory issues to assure compliance with FDA regulations, ISO standards, Corporate directives, and Company strategies.

Responsible for the scheduling, management, and related activities to data trending meetings, per the procedures established by the site and in compliance with Corporate / Unit procedures.

The Quality Specialist II will provide support to activities related to the Supplier Management program, such as the completion of Supplier Quality Interval Evaluations (SQIE) and the evaluation / approval of surveys completed by suppliers, among other tasks detailed below.

Quality Audits

• Prepare Internal Audit Schedule, in compliance with the applicable regulatory requirements and procedures established at the BD Juncos site.

• Lead and perform quality audits per the established schedule. This includes to assess the adequacy of procedures and practices of all manufacturing and non-manufacturing areas, based on regulation, technical guidance, industry standard practices, and quality trend analysis.

• Maintain appropriate records of audits records (ex. schedule, reports, meeting minutes, responses, closing evidence, effectiveness checks, etc.) in compliance with applicable procedures.

• Maintain metrics related to the internal audit program and track actions to ensure these are completed on a timely manner.

• Provide regular update to management regarding current status of the audit program with respect to audit findings, trends, audit status, and other measures of audit program (example: overdue responses, corrective and preventive actions, etc).

• Provide guidance to production and non-production areas on the identification of adequate corrective / preventive actions.

• Provide support and/or coordinate preparation for external audits with the Senior Quality Manager and/or the Auditing / Quality System Manager. This includes notification to local management, organization of records, help with the collection and evaluation of documents, data to issue audit response reports, etc.

• Attend and participate of the IDS Internal Audit Governance Board meetings.

Data Trending

• Capture the data for the monthly indicators, update the various trending sources such as: Juncos Dashboard, IDS Scorecard, etc., and disseminate, as required.

• Schedule, maintain, and lead monthly Quality Data Trend (QDT) meetings.

• Maintain appropriate records of audits records (examples: presentation, meeting minutes, action items, etc.) in compliance with applicable procedures.

• Provide support with the quarterly Management Review Meetings, as needed,

Supplier Management

• Completion of Supplier Quality Interval Evaluations (SQIE), as assigned by the BDX Supplier Audit Schedule, including but not limited to:

• Completion of SQIE for the Juncos site

• Coordinate with other using sites the completion of SQIE

• Coordinate with the Procurement the issuance of surveys to be completed by the supplier

• Evaluation and approval of surveys completed by suppliers and uploading into ARAVO and/or SharePoint, as applicable per business.

• Coordinate audits with suppliers, as applicable, per BDX Supplier Audit Schedule.

• Provide regular update to management regarding status of the audits and/or surveys assigned to the Juncos site, per the BDX Supplier Audit Schedule.

Others

• Plans, documents and participates in quality awareness and QSR/ISO training programs.

• The above responsibilities describe in a general way the nature and work level of this position. It is not intended to provide a detailed list of all the duties, responsibilities, and skills required.

KNOWLEDGE AND SKILLS

• Computer literacy required and basic knowledge of statistics.

• Accountable for ensuring compliance to QSR regulations and ISO standards

• Proficient with ISO 1345

• Organizational freedom and authority for initiating actions to prevent nonconformity, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems.

• Needs to apply principles of logical or scientific thinking to define problems, collect data, establish facts and draw valid conclusions. Interprets drawings and technical instructions furnished in written or oral form. Prepares business letters, expositions, summaries, and reports, using standard formats and conforming to rules of punctuation and grammar.

• Able to conduct training sessions; communicate verbal instructions and requirements in clear, effective manner.

• Demonstrate knowledge of operating procedures and expertise in auditing and compliance area.

• Accountable for the execution of specific tasks with moderate discretion and with oversight from a supervisor.

EDUCATION AND EXPERIENCE

• Requires a minimum of a Bachelor's Degree

• Lead Auditor Certification required

• A minimum of 5 years' experience in QC/QA areas

• Completely bilingual: English/Spanish.

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 PR Juncos - Road 31

Additional Locations

Work Shift