Quality Systems Specialist - Medical Devices & Compliance

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

Job summary

BD in San Diego seeks a quality professional to maintain and improve the IPD San Diego Design Center Quality Management System and audit readiness. You will collaborate with R&D to ensure Design Control compliance and lead internal and external audits.

The role requires at least a bachelor’s degree in science and 2 years of experience in medical devices quality systems; ISO 9001/13485 Lead Auditor is desirable.

Qualifications

• 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

Design Control

Risk Management

QMS processes

Lead Auditor

Education

Bachelor's degree in science or related discipline

Job description

BD in San Diego seeks a quality professional to maintain and improve the IPD San Diego Design Center Quality Management System and audit readiness. You will collaborate with R&D to ensure Design Control compliance and lead internal and external audits.

The role requires at least a bachelor’s degree in science and 2 years of experience in medical devices quality systems; ISO 9001/13485 Lead Auditor is desirable.