QA Engineer

Salary: $83,000 - 123,000 per year Requirements:

• We require experience in medical devices.
• We require familiarity with Class A ISO 1485.

• We own all aspects of quality assurance and quality control.
• We measure, test, evaluate, and document product performance to ensure alignment with customer and company specifications, including verification, validation, and qualification testing.
• We inspect products and carry out failure and quality-related analyses using quality and manufacturing principles, including process management, statistical analysis, and human factors.
• We use laboratory equipment such as oscilloscopes, signal analyzers, and signal generators.
• We plan the quality workload, including scheduling and charting methods such as PERT/CPM, Pareto, and Gantt, identify resource needs and risks, and oversee execution against the plan.
• We lead the resolution of customer and internal product quality issues with the goal of zero defects.
• We conduct internal, ISO 13485, ISO 9001:2016, or supplier audits when needed.
• We support ISO 13485 and ISO 9001:2016 certification activities and customer audits.
• We troubleshoot product issues, perform root cause analysis, develop timely responses and alternate solutions, and prepare formal reports and corrective actions.
• We lead continuous improvement initiatives and other cross-functional projects.
• We create and implement company policies, procedures, specifications, and end-user documentation, and ensure documents match actual practice.
• We advise on and oversee product development and production workflows.
• We partner with engineering to address hardware and software concerns and upgrades as needed.

• Hardware
• Support

More:

We are seeking a quality-focused professional to join our team in a role centered on medical device quality assurance and quality control. This position involves close collaboration with engineering and cross-functional teams, support for ISO certification and auditing activities, and a strong emphasis on continuous improvement, documentation accuracy, and achieving zero-defect performance.

last updated 38 week of 2026