Quality Systems Specialist - ISO 13485 & CAPA Lead

Solutech; Woodinville (WA); On-site; USD 85,000 - 120,000; Full time

Job summary

Solutech is seeking a Quality Systems Specialist to ensure successful implementation of ISO 13485 compliant QMS policies and procedures. This role ensures processes meet quality standards and customers' requirements for medical devices.

Responsibilities include maintaining calibration, document control, CAPA actions, audits, and training, while collaborating with procurement and regulatory teams. 1st shift, on-site in Washington state, with opportunity to impact patient care.

Qualifications

• Bachelor’s degree in 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 ability to prioritize.
• Excellent written and verbal communication skills.
• Ability to work in a team and independently.
• Ability to manage multiple projects in a fast-paced environment.
• Attention to detail and strong organizational skills.

Responsibilities

• Ensure quality procedures are followed and maintained.
• Review and revise procedures per document change control.
• Maintain calibration program and schedule equipment maintenance.
• Close customer feedback including complaints and DOA.
• Take CAPA actions for internal/external findings.
• Coordinate document control and change management.
• Support WA DOH requirements for x-ray equipment.
• Assist in internal and external audits.
• Perform final QC inspections of products before shipment.
• Monitor production methods and risk management.
• Coordinate quality awareness training and training matrix.
• Monitor customer feedback trends and identify improvements.
• Investigate non-conforming products for trends.

Skills

Quality management

ISO 13485

ISO 9001

Communication

Project management

Education

Bachelor's degree in relevant field

Job description

Solutech is seeking a Quality Systems Specialist to ensure successful implementation of ISO 13485 compliant QMS policies and procedures. This role ensures processes meet quality standards and customers' requirements for medical devices.

Responsibilities include maintaining calibration, document control, CAPA actions, audits, and training, while collaborating with procurement and regulatory teams. 1st shift, on-site in Washington state, with opportunity to impact patient care.