QA Engineer I - CTQ

Role Overview

QA Engineer I (CTQ) focused on Quality Complaint Investigation for medical device quality systems in a U.S. remote contract.

Key Responsibilities

• Investigate, review, and complete quality engineering complaint analysis tasks using quality system inputs.
• Review individual complaints and associated service data to determine risk level and document the problem code and cause codes.
• Analyze data from quality inputs such as:
  • Field Corrective Action (FCA)
  • Complaints
  • FDA Medical Device Reports (MDR)
  • (and other quality system inputs)
• Identify trends and systemic issues.
• Prepare and issue technical reports based on analysis.
• Review investigation reports and identify GMP compliance gaps.
• Develop strategies/plans to close gaps efficiently and technically.
• Define and communicate expectations for quality performance, continuous improvement, and process controls.
• Monitor and drive corrective and continuous improvement activities impacting performance measures.
• Lead corrective and preventive actions (CAPA) using formal problem-solving tools and documentation.
• Support CAPA and maintenance activities for existing product lines.
• Recommend and/or support quality system improvement projects approved by management.

Requirements

• 1–3 years of medical device experience.
• Bachelor of Science degree in Engineering.
• Strong analytical problem solving and Root Cause Analysis (RCA).
• Working knowledge of CAPA (Corrective & Preventive Action).
• Medical device quality systems knowledge, including:
  • FDA regulations such as 21 CFR 820
  • ISO 13485 / GMP
  • Complaint handling / post-market surveillance
  • Technical documentation and reporting
• Data analysis and trend identification skills.
• Experience reading and understanding blueprints/technical drawings.
• Proficiency with office and analytics tools: Word, Excel, PowerPoint, Minitab, Access, and database tools.
• Ability to manage multiple tasks/projects methodically.

Nice-to-haves

• Medical device experience specifically with 21 CFR 820.
• Statistical software experience; Minitab is a plus.
• Knowledge of CMDAS (optional).
• Knowledge/working application of ANSI/ISO/ASQC requirements.

Contract & Location

• 06+ months contract with long-term potential.
• Remote (U.S.).
• Job ID: 26-15976

Salary

• Pay range: $30–$32/hour (annual conversion not provided).