Job Description Summary

The Quality Assurance Associate is responsible for the Quality Incoming sampling and physical inspection of raw materials and components in accordance with approved drawings and specifications and contributes in the maintenance of records on vendor performance. Performs evaluation of Device History Records for completeness and compliance to specifications during manufacturing processes and prior to final product release as needed. Performs usage decisions in SAP for Raw Materials, In-process and Finished Goods. Verify that line clearance is performed after manufacturing and packaging activities. Actively participates on the analysis and resolution of supplier quality problems. Ensures that work performed conforms to QSR, ISO and OSHA standards and regulations.

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. 

The Quality Assurance Associate is responsible for the Quality Incoming sampling and physical inspection of raw materials and components in accordance with approved drawings and specifications and contributes in the maintenance of records on vendor performance. Performs evaluation of Device History Records for completeness and compliance to specifications during manufacturing processes and prior to final product release as needed. Performs usage decisions in SAP for Raw Materials, In-process and Finished Goods. Verify that line clearance is performed after manufacturing and packaging activities. Actively participates on the analysis and resolution of supplier quality problems. Ensures that work performed conforms to QSR, ISO and OSHA standards and regulations.

Responsibilities:

• Responsible for the inspection and timely disposition of raw materials and packaging components, following approved procedures and specifications. Documents inspection performed in SAP system and required forms in a timely manner.

• Responsible for the timely disposition of In-Process material following approved procedures and specifications. Documents usage decision in SAP. Ensures that all testing and documentation of manufacturing data is complete and accurate.

• Responsible for the timely disposition of Finished Goods following approved procedures and specifications. Documents product disposition in SAP. Ensures that all testing and documentation of manufacturing data is complete and accurate.

• Assures that Quality Notifications for non-conforming materials are created, investigated, completed and closed in accordance to the established Standard Operating Procedures.

• Evaluate that line clearances are performed in a timely and effective manner per establish standard operating procedures.

• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.

• Promotes a safe environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety (EH&S) programs. Address corrective actions whenever a hazard is identified.

• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.

• Performs other related duties and assignments as required.

Minimum Requirement:

• Associate Degree with five years of Quality Assurance experience in a pharmaceutical/medical device environment.

• Preferred a Bachelor Degree in a related scientific discipline (such as Chemistry, Biochemistry, Microbiology, Biology, and Engineering) and a minimum of one (1) year of quality assurance/regulatory affairs experience in a pharmaceutical/medical device environment or equivalent combination of related education and experience.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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. 

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Required Skills

Optional Skills

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Primary Work Location

USA PR Cayey - Vicks Drive (BDB)

Additional Locations

Work Shift

US BD 2nd Shift 230pm-11pm (United States of America)