Quality Engineer (QMS)

Job Description Summary

This role supports the execution of post-market quality processes by managing CAPA documentation, risk file alignment, and recall scoping activities. The position ensures accurate analysis of quality signals, facilitates CAPA investigations, and maintains compliance with regulatory requirements. It contributes to field action planning, prepares materials for internal and regulatory reviews, and provides data analytics to identify trends and support decision-making. Additionally, the role coordinates timely implementation of validated field action solutions and maintains audit ready documentation to uphold product safety and quality standards.

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.

Key Responsibilities

• Ensure that all CAPAs, Safety Alerts (SAs), Risk Assessments (RAs), Health Risk Assessments (HRAs), and Health Hazard Evaluations (HHEs) are aligned with the applicable risk files and determinations. Facilitate updates to risk documentation as needed to reflect current understanding and mitigations.

• Gather and organize data to identify affected units and customers. Assist in defining the scope of recalls and field actions, ensuring accuracy and completeness of impact analysis.

• Contribute to the development of presentations and documentation for internal Field Action Committee reviews and external regulatory communications. Ensure materials are clear, data-driven, and aligned with quality and regulatory standards.

• Drive timely development and implementation of field action solutions by analyzing complex issues, coordinating with collaborators, and ensuring solutions are robust, validated, and aligned with regulatory requirements.

• Ensure quality documentation is properly maintained and audit ready. Support audit preparation, execution, and response activities for both internal and external inspections.

• Analyze quality data to support investigations, identify trends, and generate reports. Use tools such as Excel, Power BI, or similar platforms to visualize performance and support decision-making.

• Track and manage the execution of field action solutions. Ensure that resolutions are robust, approved, validated, and released on time to customers. Coordinate with multi-functional teams to meet deadlines and regulatory commitments.

• Analyze Quality Data Trends (15% of Time) and prepare documentation for the facilitation weekly and daily management meetings with collaborators to review metrics and drive accountability. Maintain continuous tracking and reporting of performance indicators.

Ideal Background:

• B.S. Science, Engineering or other Technical Degree

• Minimum 3 years in medical device quality or regulatory support.

• Demonstrates exceptional problem-solving skills by analyzing complex dynamics, understanding stakeholder perspectives, and driving timely development and execution of robust field action solutions.

• Familiarity with CAPA, risk management, and FDA documentation.

• Strong writing and organizational skills.

• Detail-oriented and comfortable working in a fast-paced environment.

• Knowledge of ISO 14971, ISO 13485, ISO 9001, 21 CFR Part 820

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

Optional Skills

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Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$124,700.00 - $205,800.00 USD Annual