Quality Systems Specialist

Solutech; Woodinville (WA); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality management

ISO 13485

ISO 9001

Communication

Project management

Formation

Bachelor's degree in relevant field

Description du poste

Document Type: Job Description

Position Title: 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

The Core Responsibilities For This Position Include

• 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

Required qualifications include:

• 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

1st Shift