Quality System Specialist

BD Mexico; San Diego (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD is seeking a Sr Quality Systems Manager to maintain and improve the IPD San Diego Design Center Quality Management System and ensure audit readiness. You will lead audit activities, collaborate with R&D on Design Controls, and drive CAPA, training, and management reviews.

This role requires a bachelor’s degree in science, knowledge of QMS and Risk Management, and at least 2 years of medical device quality experience. Join a global leader in medical technology at the San Diego site.

Qualifications

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

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.

Skills

Quality Management

Audit Readiness

Design Control

Regulatory Compliance

Interdepartmental Collaboration

Education

Bachelor's degree in science or related field

Lead Auditor ISO 9001/13485 (desirable)

Job description

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.

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 Bldg A&B

Additional Locations

Work Shift

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 (https://jobs.bd.com/en/your-career-at-BD) ."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$105,500.00 - $168,800.00 USD Annual

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.