Job Description Summary

The Quality Systems Engineer (QSE) plays a key role in sustaining and improving the company’s Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements. This role is designed for a dynamic and capable technical leader within Quality Systems—someone who thrives on variety and is adept at driving cross-functional improvement initiatives, maintaining compliance, and implementing best practices across multiple quality processes.

The QSE will focus on the development and maintenance of meaningful quality metrics, leadership of the CAPA process (including facilitation of the CAPA Review Board), and governance of the Change Control system to ensure effective and compliant execution.

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. 

Quality System Oversight:

• Maintain and continuously improve core QMS processes including CAPA, Change Control, Document Control, Training, and Management Review.
• Serve as a subject matter expert (SME) for Quality System processes, providing guidance to multi-functional teams.

Metrics & Reporting:

• Develop, implement, and maintain key performance indicators (KPIs) and quality metrics to drive visibility and continuous improvement.
• Prepare and present QMS performance data for Management Review and other quality forums.

CAPA Management:

• Lead the end-to-end CAPA process, including root cause analysis, effectiveness checks, and closure.
• Facilitate CAPA Review Board meetings, ensuring timely and effective decision-making and documentation.
• Partner with functional leaders to drive accountability and effectiveness in corrective and preventive actions.

Change Control Governance:

• Oversee the Change Control process to ensure effective evaluation, risk assessment, and implementation of changes.
• Define and implement standard processes and training to strengthen change governance multi-functionalonal engagement.

Continuous Improvement:

• Find opportunities to streamline QMS processes, improve compliance efficiency, and enhance usability of quality systems.
• Support internal audits and regulatory inspections as a process owner or SME.
• Contribute to the development and rollout of digital tools or automation supporting QMS improvements.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field required.
• 3 years of experience in Quality Systems or Quality Engineering within the medical device, diagnostics, or other regulated industry.
• Strong working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
• Demonstrated experience leading CAPA programs and Change Control systems.
• Proven ability to develop and interpret quality metrics and drive performance improvement.
• Excellent communication, facilitation, and multi-functional collaboration skills.
• Proficiency with electronic quality management systems (eQMS) preferred.
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) a plus.
• Applicants must be authorized to work for ANY employer in the US. We are unable to sponosr or take over sponsorship of employment visa at this time.

Key Attributes:

• Hands-on, diligent, and adaptable—comfortable wearing multiple hats within a dynamic organization.
• Strong analytical and problem-solving skills.
• Collaborative approach with the ability to influence without authority.
• Committed to driving a culture of quality, compliance, and continuous improvement.

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.

Required Skills

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Primary Work Location

USA PA - Zelienople

Additional Locations

Work Shift