Position Summary
The Senior Quality Systems Engineer is responsible for developing, implementing, and maintaining Quality Management System (QMS) processes to ensure compliance with internal policies, regulatory standards (e.g., FDA, ISO), and global guidelines. This role focuses on document control, change management, CAPA, internal and external audits, and continuous improvement of quality systems. The ideal candidate will play a critical role in maintaining QMS effectiveness while driving quality excellence across the organization.
Key Responsibilities
Quality Management System (QMS) Oversight
- Implement, monitor, and maintain the effectiveness of the Quality Management System.
- Develop, review, and maintain QMS documentation, including Quality Operating Procedures (QOPs), work instructions, and records.
- Plan, lead, and execute internal audits to assess QMS effectiveness and ensure compliance with regulatory requirements.
- Prepare for and support external audits and inspections, addressing findings and driving corrective actions.
CAPA Management
- Facilitate and manage Corrective and Preventive Action (CAPA) processes to identify root causes, implement solutions, and prevent recurrence.
- Monitor CAPA progress, ensure timely resolution, and evaluate effectiveness of actions taken.
Document Control & Change Management
- Oversee document control systems, ensuring timely review, approval, and distribution of controlled documents.
- Manage change control processes, coordinating activities from initiation to implementation, while ensuring compliance with QMS requirements.
Continuous Improvement
- Identify opportunities for QMS improvements to enhance efficiency and compliance.
- Support process improvements and standardization of quality system processes across the organization.
- Develop and maintain key quality metrics, reporting trends and proposing actions for improvement.
Regulatory Compliance & Support
- Support Management Review activities by preparing data summaries and contributing to decision-making.
- Ensure compliance with FDA, ISO 13485, and other applicable regulatory and industry standards.
- Act as a quality resource for teams across the organization to ensure regulatory expectations are met.
Training & Support
- Support quality system training programs by identifying needs and coordinating training sessions.
- Serve as a subject matter expert for quality system processes, providing guidance to cross-functional teams.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- 5+ years of experience in Quality Systems within the medical device or a highly regulated industry.
- Strong working knowledge of ISO 13485, FDA QSR, and other applicable regulatory standards.
- Experience with document control, CAPA, change management, and internal/external audits.
- Proficiency with quality tools and methodologies (e.g., risk management, root cause analysis, process improvement).
- Excellent analytical, organizational, and communication skills.
- Strong ability to collaborate across cross-functional teams and manage multiple priorities.
Preferred Qualifications
- Certified Lead Auditor (ISO 13485) or experience conducting audits.
- Experience with quality management software systems (e.g., MasterControl, IMSXpress).
- Knowledge of process improvement methodologies (e.g., Lean, Six Sigma).
Benefits
- Competitive salary and performance-based bonuses
- Comprehensive health, dental, and vision benefits
- 401(k)
- Opportunities for career growth and professional development
