Quality Systems Specialist

Document Type : Job Description Position Title : Quality Systems Specialist Reports To : Regulatory Manager 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 impactwhere a team of dedicated individuals goes above and beyond to make a real difference in peoples 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 thats 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 procedureAssure calibration program is current and maintainedSchedule maintenance, cleaning and calibration for the equipment in the shop to ensure proper operationReview, coordinate, and close customer feedback (complaints, warranty, DOAs)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 maintainedEnsure all WA DOH requirements are satisfied for use of x-ray equipment Management of radiation area monitorsCollaborate with procurement to review and approve new vendorsCollaborate with procurement to evaluate the performance of current vendors and maintain vendor certifications, according to our quality procedureParticipate in internal and external auditsPerform final QC inspections of all products going out the doorPerform quarterly ESD and chemical auditsMonitor production methods, product safety / quality, and risk managementCoordinate quality awareness training for personnelMonitor and maintain site employee training matrixMonitor customer feedback on trends and opportunities for improvementMonitor non-conforming products for trends and take corrective action as neededParticipate in regular discussions with the Regulatory Manager to communicate updates, concerns, risks, resource needs, and opportunities for improvementAll other duties as assigned Qualifications Required qualifications include : Bachelors degree in relevant field or an equivalent combination of skills, training, and experience 2+ years of experience with a quality management systemKnowledge and familiarity with ISO 13485 and / or ISO 9001Good communication and project management skillsIndependent thinker and ability to prioritizeExcellent written and verbal communication skillsAbility to work in a team environment as well as independentlyAbility to work well in a fast-paced environment while managing multiple projectsAttention to detail and great organizational skills Environmental and Physical Requirements Ability to lift 75 poundsAbility to stand for long periods of timeAbility to travel, both domestically and internationally, for extended periods of timeDexterous ability to manipulate small objectsWilling to work standard and non-standard hours as required to support the customers

1st Shift

Compensation details : 55000-60000 Yearly Salary

PIe64c6751deec-26289-39566954