Staff Engineer Distribution Quality

BD-posted 3 months ago

Full-time

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As a Quality Engineer at our Distribution Center, you will be instrumental in upholding the highest standards of regulatory compliance and product quality. Your role is critical in maintaining operational excellence, with a strong focus on the quality engineering processes specific to the distribution of medical devices and pharmaceuticals. 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.

Provide engineering support to maintain a comprehensive quality management system, tailored to the distribution of medical devices and pharmaceuticals.
Ensure systems are in line with Good Distribution Practices, ISO13485 and other relevant regulatory standards.
Provide statistical data analysis in support of investigations and continuous improvement projects.
Lead or participate in qualifying suppliers within calibration, validation or temperature monitoring processes.
Monitor quality control processes in change control, temperature monitoring and validations including implementing continuous improvement strategies.
Lead validation efforts for distribution equipment, processes, and software, ensuring accuracy and reliability, including IQ/OQ/PQ protocol writing, execution and approval of protocols.
Oversee the calibration of critical instrumentation to maintain precise measurements and controls, including OOT investigations.
Manage validation vendors to ensure on time calibrations, at multiple sites, of all critical equipment.
Monitor Environmental conditions at Distribution Centers to protect product integrity.
Implement and manage controls for temperature, humidity, and other critical parameters.
Implement and manage shipping lane controls to ensure product integrity is safeguarded throughout the shipping process.
Prepare for and support both internal and external audits.
Address audit outcomes swiftly and effectively to maintain compliance.
Spearhead investigations into any quality deviations, non-conformances, or customer complaints.
Implement corrective actions to prevent recurrence and enhance quality.
Directly participate in quality investigations, including owning those investigations to closure.
Act as a reviewer and approver for quality investigations.
Maintain controlled procedures within calibration, validation, environmental controls, change control and risk management.
Ensure data from environmental controls is maintained in centralized repository.
Manage change control processes to ensure seamless transitions and compliance.
Lead change control process for designated sites.

Bachelor’s degree in engineering.
5 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.

Master’s degree in engineering.
ASQ CQA or CQE certification.
Experience with Boards of Pharmacy, licensing, and regulatory submissions.
Experience as a designated representative with state boards of pharmacy.
Five years experience with ISO 13485, certification preferred.

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