Quality System Specialist

About the Role

As a Quality Systems Specialist at Solutech, you will be instrumental in ensuring the successful implementation of ISO 13485 certified quality management system policies and procedures. You will play a crucial role in upholding processes to guarantee that products shipped to customers meet quality standards and customer requirements.

Responsibilities

• Ensure quality procedures are followed to maintain product quality.
• Revise procedures and documentation as necessary, in accordance with the document change procedure.
• Maintain and assure the calibration program is current.
• Schedule maintenance, cleaning, and calibration for shop equipment to ensure proper operation.
• Review, 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 maintained.
• Ensure all WA DOH requirements are satisfied for use of x-ray equipment.
• Manage radiation area monitors.
• Collaborate with procurement to review and approve new vendors.
• Evaluate the performance of current vendors and maintain vendor certifications, according to quality procedures.
• Participate in internal and external audits.
• Perform final QC inspections of all products before shipment.
• Perform quarterly ESD and chemical audits.
• Monitor production methods, product safety/quality, and risk management.
• Coordinate quality awareness training for personnel.
• Monitor and maintain the site employee training matrix.
• Analyze customer feedback for 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.
• Perform all other duties as assigned.

Requirements

• Bachelor’s degree in a 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 with the 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.
• Strong attention to detail and 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.
• Willingness to work standard and non-standard hours as required to support customers.