Quality System Specialist

Becton Dickinson NA; San Diego (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Job summary

Becton, Dickinson, and Company is seeking a Quality Systems professional to maintain the IPD San Diego Design Center QMS and ensure audit readiness. You will lead audit activities, collaborate with R&D on Design Control, and drive improvements across quality processes.

Ideal candidates have a bachelor's degree in science, at least 2 years in medical device quality systems, and knowledge of QMS standards. Lead Auditor certification is a plus, with a strong emphasis on cross-functional

Qualifications

• Bachelor’s degree in science or related field.
• Knowledge of Design Control, Risk Management, and QMS processes.
• Minimum 2 years of experience developing and sustaining quality systems for medical devices.
• ISO 9001/13485 Lead Auditor certification desirable.

Responsibilities

• Maintain IPD San Diego Design Center Quality Management System and audit readiness.
• Escalate negative trends and support continuous improvement of the QMS.
• Subject matter expert for audits, measurement analysis, quality plans, and document control.
• Collaborate with R&D to ensure Design Control compliance and training guidance.
• Lead internal and external audit activities, including preparation and support.
• Develop action plans and track progress; implement procedures locally.
• Support management reviews and ensure alignment with requirements.
• Monitor monthly quality metrics and address negative trends.
• Maintain quality agreements with internal customers and suppliers.
• Provide training on quality processes and regulatory requirements.

Skills

Quality Management

Regulatory Compliance

Audit Readiness

Process Improvement

Education

Bachelor's degree in science

Job description

NEW Full Time We are the people who give possibilities purpose

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.

Job Description

Reports to the Sr Quality Systems Manager and is responsible for maintenance and improvement of IPD San Diego Design Center Quality Management System and Audit readiness

Responsibilities

• Maintain the IPD San Diego Design Center in compliance with applicable regulations and standards, corporate and business unit policies and procedures.
• Escalate negative trends to management and support continuous improvement of the QMS.
• Subject Matter expert for audit and inspections, measurement analysis and improvement, Quality plans, and document and record control.
• Collaborate with R&D to ensure compliance with Design Control requirements. Support improvement of Design Control procedures, establish control points to assess compliance, and provide training and guidance.
• Lead internal and external audit related activities, including audit preparation, front room and backroom support, and Audit
• Action Plans development and tracking.
• Implement Corporate, Business, and local Quality System procedures for the IPD San Diego design center locations.
• Support the management review process. Prepare and review content, ensure management review complies with requirements, and drive process improvements.
• Ensure monthly quality metrics are submitted and take action to address negative trends.
• Provide inputs on revisions to corporate and business level procedures as necessary.
• Maintain outsourcing relationships with internal customers and suppliers by management of quality agreements.
• Communicate with stakeholders at all levels, including management, peers, and key stakeholders.
• Provide training and support to employees on quality processes and procedures.
• Execute, measure and report on the progress of Quality strategic initiatives as required.
• Stay up to date on emerging trends and technologies in quality management and regulatory requirements.
• Backup the CAPA and Training / Documentation Coordinator.

Minimum Requirement

• 1. A minimum bachelor's degree in science or a related discipline.
• 2. Knowledge of Design Control, Risk Management, and QMS processes.
• 3. Minimum 2 years of experience developing and sustaining quality systems for medical devices.
• 4. Certified ISO 9001/13485 Lead Auditor is desirable.

Why Join Us?

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 healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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.

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under " Our Commitment to You .

Primary Work Location

USA CA - San Diego Bldg A&B

Salary Range Information

$105,500.00 - $168,800.00 USD Annual Location/Region: San Diego, California