Job Title: Quality Assurance Engineer I - CTQ

Job Description

We are seeking a Quality Assurance Engineer who will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products while also enabling speed to market. You will partner with engineering teams in the development of medical devices to ensure safety and efficacy are demonstrated, identifying and mitigating risks throughout the process.

Responsibilities

• Ensure compilation and maintenance of product Design History Files (DHF) and perform DHF audits as an independent reviewer.
• Archive paper device and design history records in an electronic searchable format.
• Analyze post-market quality data, complaint, and service data, summarizing it into easy-to-read failure analysis.
• Document traceability of requirements through design output and to design verification and/or design validation.
• Guide the use of robust statistical techniques throughout new product development and design changes.
• Support external regulator or customer audits.
• Perform other duties as requested.

Essential Skills

• Attention to detail and focus.
• Organizational skills.
• Proficiency in Microsoft Office.
• Systems design control competency.
• 1 year of experience in quality system documentation.
• 1-2 years reviewing and/or filing quality records.
• 1 year of experience processing large complaint datasets.

Additional Skills & Qualifications

• Bachelor's degree in engineering is preferred, but equivalent work experience may be sufficient.
• Medical device manufacturing experience is advantageous.
• Experience archiving and conciliating Design History Records (DHRs).
• Experience drafting design Failure Mode and Effects Analyses (FMEAs).
• Strong working knowledge of design controls as required by FDA 21 CFR 820.30 and ISO standards.
• Demonstrated ability to analyze, evaluate, and control risk following lifecycle risk management standards.
• Understanding of statistical analysis techniques and tools.
• ASQ or related quality certification is preferred.
• Work experience in an FDA regulated environment is preferred.
• Proficiency in reading and understanding technical product documentation, diagrams, schematics, and flow-charts.
• Comfortable using PC tools and Windows OS with a working knowledge of local and network-based file systems.
• Excellent verbal and written communication skills in English.
• Ability to work independently and as part of a team.
• Proactive and timely in the execution of assigned tasks.
• Flexibility and adaptability when needs and priorities change.

Work Environment

This position is based onsite in Milwaukee, WI, working a 40-hour week from 8:30 AM to 4:30 PM. The role involves sitting for extended periods, using a computer, and communicating both in-person and over the phone. The work environment is an office setting with a minimal noise level.