Quality Engineer View Details

Job Summary

This position involves technical leadership and analytical skills in resolving production issues, implementing process improvements, and developing new tools, fixtures, and software. It requires close collaboration with design and mechanical engineers and involves preparing technical reports, drafting and executing process/software validations.

Duties And Responsibilities

• Review prototype, test instructions, and schematics to ascertain test specifications, procedures, and objectives.
• Interpret engineering prototypes, test instructions, and schematics to identify, modify, and plan requirements for fabrication, assembly, testing, and test nature of technical problems.
• Participate on new product release teams from the earliest phases to employ design for manufacturing concepts and facilitate a smooth transition from Engineering to Manufacturing.
• Owes the development of assembly processes for new products and the introduction of new methods into the assembly processes of current products and associated PFMEA's.
• Devise, fabricate, and assemble new or modified assembly and test fixtures using appropriate machine shop and/or hand tools or software modules.
• Apply DOE and statistical tools to identify root cause(s) of yield loss and propose and implement corrective actions, make recommendations for changes in test fixtures or test methods by applying theory & principles of mechanical engineering.
• Maintain Work Instructions, BOM’s, preventative maintenance schedules, and Routers. Record test procedures and results; write test reports using numerical and graphical data using Excel and Word.
• Confer with engineering staff and submit reports of test results to engineering department and recommend design or material changes.
• Actively participate in discussions related to changes in design, method of manufacture and assembly, and drafting techniques and procedures with staff and coordinate corrections.
• Document software specifications for review prior to development of software.
• Develop and release software in a controlled manner, ensure developmental software is not active prior to validation and release.
• Identify and resolve manufacturing errors expeditiously with attention to impact on safety/ergonomics, quality, cost, and production schedules from software.

Education And Experience

• BS in Mechanical, Manufacturing, or Biomedical Engineering required.
• MS in Mechanical or Biomedical Engineering preferred.
• Minimum of two years’ experience.
• Preferred is prior experience in medical device industry and familiarity with FDA CGMP regulations.
• Proficiency in 3D Modeling required.
• Proficiency in LabVIEW programming preferred.
• Experience in systems design.

Quality Engineer

The Quality Engineer supports the quality, reliability, and compliance of Transonic’s ISO 13485 Quality Management System and medical device products. The primary focus is complaint handling, failure analysis, monitoring standards and regulations, and ECO scoping. This role also provides backup support for deviation processes, minor audits, and Management Review data preparation.

Duties And Responsibilities

• Manage and support the complaint handling process, including complaint intake, tracking, follow-up, documentation review, and timely closure.
• Coordinate with Regulatory Affairs to support complaint reportability assessments and ensure required regulatory timelines are met.
• Lead or support periodic cross-functional complaint meetings to review new complaints, open complaint activities, overdue actions, failure analysis status, and closure progress.
• Monitor failure analysis activities related to complaints and follow up with responsible departments such as Repair, Manufacturing Engineering, Engineering, Manufacturing, and Quality Assurance.
• Ensure complaint records are complete, accurate, and documented in accordance with applicable Quality System and regulatory requirements.
• Lead Engineering Change Order scoping activities across the company, including scheduling cross-functional ECO scoping meetings, reviewing proposed changes with impacted departments, ensuring the full scope and impact of changes are assessed, and confirming that required documentation, implementation tasks, and follow-up actions are identified before ECO release.
• Provide backup support for other ECO activities, including technical review support, follow-up documentation, implementation task tracking, and closure support as needed.
• Provide backup support for the deviation process, including deviation documentation, routing, review follow-up, impact assessment support, and tracking of assigned actions through closure.
• Aid in ensuring deviations are properly documented, reviewed, and closed in accordance with Quality System requirements.
• Support standards and regulation monitoring, including review of applicable ISO, FDA, MDR, MDSAP, and other regulatory or Quality System requirements.
• Communicate relevant standards or regulatory updates to appropriate Quality, Regulatory, Engineering, Manufacturing, and leadership teams as needed.
• Assess the potential impact of updated standards or regulatory expectations on Quality System processes, procedures, documentation, or product-related activities.
• Participate in internal and external audits, including audit preparation, audit support, documentation review, audit response support, and follow-up on audit findings.
• Prepare, compile, and present quarterly Management Review data to the Senior Leadership Team, including Quality metrics, complaint trends, FAR status, ECO status, and deviation status.
• Review quality data for trends, gaps, and potential areas of concern, and communicate findings to Quality leadership.
• Assist with continuous improvement activities, including identifying process gaps, supporting corrective actions, improving documentation, and helping strengthen Quality System effectiveness.
• Support the QA team with other work-related duties as requested, directed, or assigned by management.

Education And Experience

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related technical field required.
• 3+ years of experience in quality engineering, quality assurance, complaint handling, or regulated manufacturing preferred.
• Prior experience in a regulated environment, preferably medical device, ISO 13485, FDA, MDR, MDSAP, or similar regulated industry, is preferred.