Jobs

Description

Description:

• The incumbent will design and maintain a complaint tracking and reporting system; evaluate medical and non-medical complaints and stability investigation requests and make technical judgment on the nature of the problem; evaluate shipping, manufacturing, equipment, validation, engineering project, testing/inspection results, product specifications, employee training records as well as Basic Operating Procedures, SPC/quality trend data, and or stability reports, as applicable, to determine the root causes of the problem.
• The reviewer expert it own judgment based on experience to determine the depth of the investigation required associated the level of risk of non-conformance.
• Maintain a tracking and follow up-system to ensure compliance of Quality Engineering with the FDA Quality Systems Inspection Techniques.

Quality Engineering Analyst (Tracking & Trending)

Position Overview

• Our client is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment.
• This role is responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives.
• The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.

Experience Required

• 2 to 3 years of experience in a:
• Medical device industry (preferred)
• Pharmaceutical industry
• FDA and/or ISO regulated environment

Required Education

Bachelor's Degree in:

• Biomedical Engineering, or
• Related Engineering Discipline

Preferred Certifications

• ASQ Certified Quality Engineer (CQE) or equivalent certification preferred
• Required Technical Skills

Candidates should possess experience in the following areas:

• Quality data analysis and trending investigations
• Complaint handling and complaint trend analysis
• CAPA support and root cause investigation methodologies
• Quality systems within FDA-regulated environments
• Data analysis and reporting using Excel and related analytics tools
• Cross-functional collaboration with Quality, Operations, Manufacturing, and R&D teams

Preferred Qualifications

Strong preference for candidates with experience in:

• JMP
• Advanced Microsoft Excel
• SQL querying and data analysis
• Power BI
• Basic to intermediate Python programming
• Quality and complaint management databases
• Dashboard development and data visualization

Key Responsibilities

• Perform complaint tracking and trending activities using quality databases and analytical tools.
• Analyze complaint, CAPA, and quality system data to identify trends, risks, and emerging issues.
• Support root cause investigations and CAPA activities.
• Create dashboards, reports, and data visualizations utilizing Excel, Power BI, JMP, SQL, and Python.
• Partner with Quality, Operations, Manufacturing, and R&D teams to investigate product and process concerns.
• Document investigative findings and support regulatory compliance requirements.
• Assist with continuous improvement initiatives related to complaint handling and quality trending processes.
• Present findings, recommendations, and data-driven insights to stakeholders.

The ideal candidate will have:

• Experience working in a medical device or other highly regulated environment.
• Strong analytical and problem-solving capabilities.
• Experience analyzing complaint and quality data.
• Exposure to CAPA processes and root cause investigations.
• Ability to communicate technical findings clearly to cross-functional stakeholders.
• Proficiency with data analytics and reporting tools.