Job Description Summary

The QA Specialist I will be responsible for supporting the preparation, creation, and maintenance of various types of documents such as quality documents and manufacturing specifications for BD products and services. Works with cross-functional associates who are submitting and reviewing information for the preparation of various documents to ensure accuracy and appropriate format per company standards. Work is closely supervised.

Develops and implements programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement. Develops policies, procedures, and methods to check product, material, components, and/or operational quality and improve same. Responsible for developing and implementing a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective.

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. 

General Responsibilities and Duties:

• Develops solutions to routine assigned activities of minimal scope & complexity. Follow applicable Company / Unit procedures.

• Proactively handles personal metrics to ensure goals are tracked and met. Works within function for assigned Quality systems.

• Perform tasks of minimal complexity within planned schedules and timelines. Support audits and ensure documentation compliance.

Functional Responsibilities

• Check document records for discrepancies against information provided in Change Management records (i.e. redlines).

• Consult with department supervisor and Change Order Requesters to resolve discrepancies and issues.

• Help in trouble-shooting document formatting challenges and supply assistance to associates within department and other cross-functional groups, as necessary.

• Support new and sustaining product team activities to assist product release.

• Perform data entry functions as required by business processes and responsibilities.

• Ensure all document processing occurs in a timely manner and perform the necessary follow-up to prevent any conflicts or delays to business goals.

• May assist with the training and development of other associates within the company.

• Maintain all assigned training requirements.

• Keep abreast of the basic requirements for compliance in own area of work and comply with those requirements.

• Contribute to the completion of routine technical tasks within applicable quality systems.

• Use standard and approved Quality/Compliance methods (Good Documentation practices).

• Develop solutions to routine assigned activities of limited scope (e.g. Document change, Complaint file entry, CAPA documentation).

• Decisions, recommendations, and results cause minimal to moderate impact on project schedules.

• Notify manager upon recognition of factors that may affect project.

• Record and document work of self.

• Perform development as assigned.

• Exercise sound judgment within generally defined practices and policies for obtaining solutions, including participating in any discussions that are required to resolve open issues.

Required Qualifications:

• Bachelor's degree with minimum one year of medical device industry experience;

• Working knowledge of ISO 13485 requirements

• Solid understanding of SAP and MS Office products (advanced level)

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 wor