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. 

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, 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.

• 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 ensure product integrity is safeguarded throughout the shipping process.

• Audit and Compliance Readiness:

  • Prepare for 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

• 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 centralized repository.

  • Manage change control processes to ensure seamless transitions and compliance.

  • Lead change control process for designated sites.

Required Qualifications:

• Bachelor’s degree in engineering

• 5 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.

Preferred Qualifications:

• 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

Skills:

• Excellent problem-solving skills with the ability to think critically and creatively.

• Experience working with ERP systems.

• Knowledge of FDA regulations and ISO standards related to medical device manufacturing.

• Five years experience with ISO 13485, certification preferred

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 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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