Quality Specialist

This range is provided by Medi View XR, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$80,000.00/yr - $/yr

The Quality Specialist will manage quality records, assist in investigation and resolution of defects, engage with new product development deliverables, plan and execute test activities for software features, and ensure post market surveillance is consistent with applicable regulations, standards, and established procedures.

• Develop, implement, and maintain test methodologies, test plans, protocols, test scripts, test reports and traceability matrices for Medi View platforms. Resolve complaints, nonconformances and CAPAs to support post‑market evaluation and data analysis.
• Analyze data from test activities, interpret results, and prepare technical documentation to provide visibility into product readiness, quality, and reliability.
• Conduct functional, performance, reliability and Human Factors testing of devices to ensure compliance with quality standards and regulations.
• Perform manual testing of new software features and interfaces.
• Document and track defects and bugs, and, with assistance from Software Quality Assurance, analyze root causes and follow up on fixes.
• Partner with other members of the Quality team to develop, implement, and maintain test methodologies, test plans, protocols, test scripts, test reports and traceability matrices for Medi View platforms.
• Assist in triage, investigation, and resolution of software and hardware defects.
• Identify plans and execute test process improvements to continually improve the performance of the Quality team and QMS at large.
• Provide quality support to design teams; this includes input into the bench and pre‑clinical test requirements and participating in risk management meetings and related activities such as verification of risk mitigation implementation in products and processes as needed.
• Support Internal Quality Audits and the audit program as needed.
• Support health authority audits and external audits.
• Proactively drive continuous improvement initiatives related to the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Collaborate with regulatory affairs to ensure testing procedures meet industry standards and compliance requirements.
• Perform all activities in compliance with the Quality System.
• Perform all other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Education and/or Experience – Bachelor’s degree in engineering is preferred. Minimum of 2 years’ experience in the medical device industry developing class II and class III devices. Experience working with engineering team to partner and understand system requirements is preferred. Experience with conducting Human Factors Engineering evaluations is preferred.
• Software Platform – Working knowledge of document control, eQMS, and other software platforms utilized within the medical device industry.
• Language Skills – Strong communication skills such as written, verbal, and public speaking. Ability to read, analyze, and interpret common scientific and technical journals. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to management, public groups, and/or board of directors. Ability to interact clearly and effectively, in both written and oral communication, with supervisor, clients, staff, vendors, etc.
• Mathematical Skills – Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Computer…