Job Description Summary

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. 

Summary

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.

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 and other relevant regulatory standards.

Quality Operations Oversight

• Conduct thorough equipment and process inspections and guarantee compliance with standard operating procedures.
• Monitor quality control processes and implement continuous improvement strategies.

Validation and Calibration Expertise

• Lead validation efforts for distribution equipment, processes, and software, ensuring accuracy and reliability.
• Oversee the calibration of critical instrumentation to maintain precise measurements and controls.

Environmental Monitoring

• Vigilantly monitor environmental conditions within the Distribution Center 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.

Audit and Compliance Readiness

• Prepare for, coordinate, and support both internal and external audits.
• Address audit outcomes swiftly and effectively to maintain compliance.

Quality Incident Investigation

• 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.

Product Traceability

• Ensure a robust traceability system is in place for all products, safeguarding their integrity throughout the distribution chain.

Customer Quality Claims Resolution

• Investigate and resolve any claims regarding service failures or product quality.

Document and Change Management

• Maintain meticulous control over all quality-related documentation.
• Manage change control processes to ensure seamless transitions and compliance.

Risk Management

• Proactively identify and mitigate potential risks to quality and compliance within the distribution environment.
• Utilize Risk Management tools including pFMEA to ensure appropriate risk measurements and mitigations are in place.

Regulatory Compliance

• Stay abreast of licensing requirements and ensure the Distribution Center’s full compliance.

Qualifications

Education and Experience

• Bachelor’s degree in a relevant field; advanced degree preferred.
• At least 2 years of experience in quality engineering, preferably within a distribution center for medical devices and pharmaceuticals.
• ASQ CQA or CQE certification is highly desirable.
• Experience with Boards of Pharmacy, licensing, and regulatory submissions is a plus.
• Experience as a designated representative with state boards of pharmacy is a plus.

Knowledge and Skills

• Proficiency in quality audits and regulatory standards such as GDP, 21 CFR 820, 21 CFR Part 11, and ISO 13485.
• Strong leadership, organizational, and communication skills.

Travel

• Expected travel can be up to 25% of the time.

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. 

Required Skills

Optional Skills

.

Primary Work Location

Additional Locations

Work Shift