Quality Systems Specialist - ISO 13485 & CAPA Expert

RSA LLC; Washington (District of Columbia); On-site; USD 80,000 - 110,000; Full time

Job summary

Solutech is seeking a Quality Systems Specialist to oversee ISO 13485 compliant quality management practices and ensure all products meet stringent quality standards. You will drive documentation control, CAPA actions, internal/external audits, and coordination with procurement on vendor certification.

The role requires hands-on experience with quality systems, strong communication, and the ability to work in a fast-paced medical device environment under the guidance of the Director of Quality &

Qualifications

• Bachelor’s degree in a relevant field or equivalent experience.
• 2+ years of experience with a quality management system.
• Knowledge of ISO 13485 and/or ISO 9001.
• Strong communication and project management skills.
• Independent thinker with the ability to prioritize and work both independently and in a team.

Responsibilities

• Implement and maintain ISO 13485 compliant quality management system policies and procedures.
• Ensure products meet quality standards and customer requirements.
• Revise procedures and documentation per change control.
• Coordinate calibration, maintenance, and inspection of shop equipment.
• Review and close customer feedback, complaints, and DOAs; take corrective actions as needed.
• Support audits and participate in CAPA processes.
• Maintain document control and change management; ensure regulatory requirements are satisfied.
• Collaborate with procurement on vendor reviews and certifications.
• Perform final QC inspections and monitor product safety and risk.

Skills

Quality systems

ISO 13485

Documentation

Project management

Communication

Prioritization

Team player

Attention to detail

Education

Bachelor’s degree in relevant field

Job description

Solutech is seeking a Quality Systems Specialist to oversee ISO 13485 compliant quality management practices and ensure all products meet stringent quality standards. You will drive documentation control, CAPA actions, internal/external audits, and coordination with procurement on vendor certification.

The role requires hands-on experience with quality systems, strong communication, and the ability to work in a fast-paced medical device environment under the guidance of the Director of Quality &