We are the people who give possibilities purpose

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.

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. 

Job Summary
The Quality System Specialist - Product Release at BD Puerto Rico LLC is responsible for ensuring the timely and compliant release of manufactured products by meticulously reviewing documentation and verifying adherence to established quality system requirements, regulatory standards, and internal procedures. This role plays a critical part in maintaining product quality and patient safety.

Job Responsibilities

• Perform comprehensive review of device history records (DHRs), batch records, and other relevant production documentation to ensure accuracy, completeness, and compliance with specifications and procedures.

• Verify all quality control checks, in-process testing, and final product testing results meet acceptance criteria.

• Ensure that the latest revised forms are being used.

• Perform, Review and/or approve Certificates of Analysis (COAs) and other release documentation.

• Initiate and manage the resolution of discrepancies or non-conformances identified during the product release process, collaborating with relevant departments.

• Assists in validation activities with the review of DHRs, as required.

• Ensure all necessary quality system elements, such as calibration, training, and environmental monitoring, are in place and compliant prior to product release.

• Maintain accurate and organized records of all released products and associated documentation.

• Participate in internal and external audits as a subject matter expert for product release processes.

• Support the Material Review Board (MRB) meetings to complete investigation and product disposition for QNs in SAP.

• Contribute to the continuous improvement of product release processes and procedures.

• Maintain monthly metrics for DHR RTFT.

• Collaborate with manufacturing, quality engineering, regulatory affairs, and other cross-functional teams to facilitate efficient product flow and resolve quality-related issues.

• Stay current with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and internal quality system requirements.

• Other tasks and duties might be assigned, as required.

Job Qualifications

• Bachelor's degree in a sciences or equivalent.

• Minimum of 2 years of experience in a regulated manufacturing environment, preferably in the medical device or pharmaceutical industry.

• Demonstrated knowledge of Quality System Regulations (21 CFR Part 820), ISO 13485, and other relevant international quality standards.

• Strong attention to detail and excellent analytical skills for reviewing complex documentation.

• Proficiency in interpreting and applying quality procedures, specifications, and regulatory requirements.

• Ability to identify, investigate, and resolve quality-related issues efficiently.

• Effective communication skills, both written and verbal, for interacting with various levels of the organization.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

• Experience with Enterprise Resource Planning (ERP) systems (e.g., SAP) and Quality Management Systems (QMS) is highly desirable.

• Ability to work independently and as part of a team in a fast-paced environment.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

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Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

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