Quality Engineer II

Job Description Summary

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 Med Tech 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. Our people make all the difference in our success.

The Quality Engineer II is responsible for applying/interpreting the Quality Systems, technical principles, theories, concepts, techniques, and quality sciences (Microbiology or related) for assigned product and related manufacturing areas. This position is responsible for supporting related BD quality processes and procedures, including Complaint Handling and responding to Quality Queries from the customers and commercial team. Primary job functions will be to author and/or review complaint investigation summary reports and other post market functions as required.

This role will have primary focus on PMS (Post Market Surveillance) activities—including, but not limited to customer complaints, CID/CAPA, SA/FA, Quality metrics and complaint data analysis. Responsibilities include monitoring, investigating and trending customer complaints for manufactured and distributed components/products. Assesses Critical to Quality (CTQ) parameters and risk assessment variables as part of the decision‑making processes to support predictable product design and flow.

Initiates and/or supports CAPAs and may lead the investigation/corrective action process. Initiates and/or supports Situation Analysis and/or Field action process. Initiates and/or supports change notifications (change controls). Responsible for the various aspects of Media QM Engineering as well as day‑to‑day QM Engineering responsibilities for assigned products and related operational area projects. Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems.

May support both internal and external audits as a Subject Matter Expert (SME). Is also responsible for assuring departmental compliance with ISO and FDA requirements participation on teams, assigned project support, product launches and process improvements, product quality notifications, and IVDR compliance. This includes using Enterprise tools to ensure compliance and streamline processes. Other duties as assigned based on business needs.

Bachelor’s Degree in Biological Sciences, Chemistry, Regulatory Affairs, or a related field with 2+ years of experience in Quality Assurance, Quality Control or Product/Process Non‑Conformance Investigations or Master’s Degree with 1+ years of relative experience. This is a position that requires onsite support. Preferred and additional skills and qualifications:
Experience in a medical device or pharmaceutical manufacturing facility. Position requires a sound Quality or technical/Engineering background. Attention to detail and a commitment to quality. Ability and skill to effectively manage multiple tasks and drive execution of change management plans. SAP transaction experience. Proficiency in technical writing and documentation. Excellent communication and interpersonal skills with ability to build strong relationships internally and externally.

Ability to speak with clarity and express points of view in a variety of settings; one‑on‑one interactions, group meetings, and formal presentations. Strong analytical and problem‑solving skills with ability to identify root causes and develop solutions. Persistence to drive to solutions despite obstacles and/or competing priorities. Proficiency in Microsoft Office Suite required, particularly Excel…