QA Technician

Job Function: Quality Assurance & Regulatory  Job: QA Technician Location: Middleton, Wisconsin, USA   Job Overview The QA Technician supports quality assurance activities within a regulated medical device manufacturing environment. This role ensures compliance with quality systems and internal procedures through inspection, documentation review, and product release activities. The position plays a key role in incoming inspection, Device History Record (DHR) review and release, and maintaining audit-ready quality records. The QA Technician works cross-functionally to support product quality, compliance, and continuous improvement initiatives. Key Responsibilities Perform incoming inspection of materials/components and review supplier documentation (CoC/CoA). Conduct thorough DHR reviews to ensure completeness, accuracy, and compliance prior to product release. Approve and release finished product in line with established procedures. Identify, document, and support investigation of non-conformances. Maintain accurate, complete, and audit-ready quality records. Support internal/external audits and inspections. Maintain Preventative Maintenance (PM) and calibration schedules; ensure equipment is within calibration. Review and update procedures, work instructions, and forms as required. Identify and support implementation of process improvements. Communicate effectively with cross-functional teams (Manufacturing, Engineering, Supply Chain, QA). Support training on QA processes and procedures. Adhere to all safety and quality requirements and promote a culture of compliance and continuous improvement. Level Expectations Performs routine to moderately complex tasks with a high degree of independence. Applies working knowledge of quality systems and manufacturing processes. Exercises judgment in inspection, documentation review, and release decisions. Works with minimal supervision and takes ownership of assigned tasks. Supports team coordination and continuous improvement initiatives. Experience & Qualifications Experience: 3–5 years in a regulated manufacturing environment (medical device preferred). Experience in incoming inspection, documentation review, and product release. Skills: Strong knowledge of quality systems and documentation practices. Experience with inspection methods and measurement tools. Familiarity with non-conformance handling and root cause analysis. High attention to detail, organization, and problem-solving skills. Effective communication and teamwork. Key Behaviors Patient and quality focused Detail-oriented and compliant Accountable and proactive Collaborative and adaptable Continuous improvement mindset