MedTech Quality Systems Specialist — Audit & Compliance

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

Job summary

BD in San Diego is seeking a qualified professional to maintain and improve the Design Center Quality Management System and audit readiness. Reporting to the Sr Quality Systems Manager, you will lead audit activities, CAPA management, and document control, while collaborating with R&D on Design Control requirements to ensure compliance.

The role requires a bachelor’s degree in science or related discipline and at least 2 years of experience with medical devices’ quality systems; ISO 9001/13485

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, standards, 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, and support improvement of Design Control procedures.
• Lead internal and external audit related activities, including audit preparation and support.
• Action Plans development and tracking.
• Implement Corporate, Business, and local Quality System procedures for the IPD San Diego design center locations.

Skills

Design Control

Risk Management

QMS processes

Education

Bachelor's degree in science or related discipline

Job description

BD in San Diego is seeking a qualified professional to maintain and improve the Design Center Quality Management System and audit readiness. Reporting to the Sr Quality Systems Manager, you will lead audit activities, CAPA management, and document control, while collaborating with R&D on Design Control requirements to ensure compliance.

The role requires a bachelor’s degree in science or related discipline and at least 2 years of experience with medical devices’ quality systems; ISO 9001/13485