Staff Engineer Distribution Quality

Overview

Job Description Summary : As a Quality Engineer at our Distribution Center, you will be instrumental in upholding regulatory compliance and product quality, with a focus on quality engineering processes for the distribution of medical devices and pharmaceuticals.

Job Description : BD is one of the largest global medical technology companies. We pursue the purpose of advancing the world of health and strive to enable our teams to learn, grow and become their best selves. Become a maker of possible with us.

Responsibilities

• Quality System Management : 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, ISO 13485 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.
• Quality Operations Oversight : Monitor quality control processes in change control, temperature monitoring and validations, including implementing continuous improvement strategies.
• Validation and Calibration Expertise : 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.
• Environmental Monitoring : 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 safeguard product integrity during shipping.
• Audit and Compliance Readiness : Prepare for and support internal and external audits. Address audit outcomes swiftly and effectively to maintain compliance.
• Quality Incident Investigation : Spearhead investigations into quality deviations, non-conformances, or customer complaints. Implement corrective actions to prevent recurrence and drive quality improvements. Directly participate in investigations, including ownership to closure and acting as a reviewer and approver for quality investigations.
• Document and Change Management : Maintain controlled procedures within calibration, validation, environmental controls, change control and risk management. Ensure data from environmental controls is maintained in a centralized repository. Manage change control processes to ensure seamless transitions and compliance. Lead change control process for designated sites.

Required Qualifications

Preferred Qualifications

Skills

Work Location & Schedule

Primary Work Location : USA GA – Covington Global Dist Center

Work Shift : See job posting for details

Work Policy

At BD, we prioritize on-site collaboration to foster creativity, innovation, and effective problem-solving. For most roles, a minimum of 4 days in-office per week is preferred, with flexibility and work-life balance considered. Remote or field-based positions will have different arrangements indicated in the job posting.

For certain roles at BD, employment is contingent upon proof of full vaccination against COVID-19. In some locations, testing may be available or required. BD's Workplace Accommodations Policy applies, and 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, encourages authentic self-expression, and supports ongoing learning and improvement.

To learn more about BD, visit the company website. 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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