Quality Systems Specialist

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

Quality Systems Specialist

Reports To

Director of Quality & Regulatory Services

Revised: 05/14/2025

Company Overview

At Solutech, our mission is to ensure critical medical devices are always available to support the treatment and diagnosis of patients when they need it most. Our culture is driven by a shared commitment to making a positive impact—where a team of dedicated individuals goes above and beyond to make a real difference in people’s lives. As part of our team, you'll have the unique opportunity to help shape the future of medical device services. If you want to be part of a team that’s truly making an impact in the healthcare industry, this is the perfect opportunity. To make you a hero for your patients, we go the mile after the extra mile – We are the Solutionists of Solutech.

Functional Description

The Quality Systems Specialist is instrumental in ensuring the successful implementation of ISO 13485 certified quality management system policies and procedures. They play a crucial role in ensuring that processes are upheld and that products shipped to customers meet standards of quality and customers’ requirements.

Scope of Outcomes

• Ensure quality procedures are being followed to ensure quality
• Revise procedures and documentation as necessary, in accordance with the document change procedure
• Assure calibration program is current and maintained
• Schedule maintenance, cleaning and calibration for the equipment in the shop to ensure proper operation
• Review, coordinate, and close customer feedback (complaints, warranty, DOA’s)
• Take appropriate corrective action in accordance with the CAPA process (internal findings, external findings, customer complaints, etc.)
• Ensure document control and change management processes are maintained
• Ensure all WA DOH requirements are satisfied for use of x-ray equipment
• Management of radiation area monitors
• Collaborate with procurement to review and approve new vendors
• Collaborate with procurement to evaluate the performance of current vendors and maintain vendor certifications, according to our quality procedure
• Participate in internal and external audits
• Perform final QC inspections of all products going out the door
• Perform quarterly ESD and chemical audits
• Monitor production methods, product safety/quality, and risk management
• Coordinate quality awareness training for personnel
• Monitor and maintain site employee training matrix
• Monitor customer feedback on trends and opportunities for improvement
• Monitor non-conforming products for trends and take corrective action as needed
• Participate in regular discussions with the Regulatory Manager to communicate updates, concerns, risks, resource needs, and opportunities for improvement
• All other duties as assigned

Qualifications

• Bachelor’s degree in relevant field or an equivalent combination of skills, training, and experience
• 2+ years of experience with a quality management system
• Knowledge and familiarity with ISO 13485 and/or ISO 9001
• Good communication and project management skills
• Independent thinker and ability to prioritize
• Excellent written and verbal communication skills
• Ability to work in a team environment as well as independently
• Ability to work well in a fast-paced environment while managing multiple projects
• Attention to detail and great organizational skills

Environmental and Physical Requirements

• Ability to lift 75 pounds
• Ability to stand for long periods of time
• Ability to travel, both domestically and internationally, for extended periods of time
• Dexterous ability to manipulate small objects
• Willing to work standard and non-standard hours as required to support the customers

Shift

1st Shift