Quality System Specialist

Becton Dickinson Medical Devices • San Diego, CA

2d • Onsite

About The Position

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.

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.

Requirements

• A minimum bachelor’s degree in science or a related discipline.
• Knowledge of Design Control, Risk Management, and QMS processes.
• Minimum 2 years of experience developing and sustaining quality systems for medical devices.

Nice To Haves

• 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.

Benefits

• 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 ."
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level