Quality Engineer

Katalyst CRO; Dexter (MI); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Quality Complaint Investigator to support complaint investigations, CAPA activities, and continuous improvement in a regulated medical device environment. Responsibilities include root cause analysis, data-driven reporting, and ensuring FDA and GMP compliance.

The role requires a bachelor's degree in engineering and 13 years of Medical Device experience, with strong analytical skills and proficiency in MS Office.

Qualifications

• Bachelor's degree in engineering required.
• 13 years of Medical Device industry experience.
• Familiarity with FDA QSR 21 CFR 820 and cGMPs required.
• Experience with complaint handling, investigations, and root cause analysis.
• Capable of supporting CAPA processes and quality systems.

Responsibilities

• Review customer complaints and service data to assess risk and codes.
• Conduct investigations and perform root cause analysis.
• Analyze data from quality systems (Complaints, FCA, FDA MDRs) for trends.
• Prepare investigation summaries, reports, and recommendations.
• Identify GMP gaps and support CAPA development and implementation.
• Collaborate cross-functionally to improve product quality and compliance.

Skills

Data analysis

Root cause analysis

CAPA processes

Regulatory compliance

Problem solving

Cross-functional

MS Office

Documentation

Education

Bachelor's degree in engineering

Tools

Minitab

Excel

Word

PowerPoint

Job description

Job Description

We are seeking a Quality Complaint Investigator to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA activities, and ensuring compliance with FDA and GMP standards.

Responsibilities

• Review customer complaints and associated service data to determine risk levels and identify problem/cause codes.
• Conduct complaint investigations and perform detailed root cause analysis.
• Analyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issues.
• Prepare investigation summaries, reports, and recommendations based on analysis.
• Review existing investigation reports and identify GMP compliance gaps.
• Support development and implementation of corrective and preventive actions (CAPA).
• Drive continuous improvement initiatives and process control activities.
• Conduct data analysis using statistical and quality tools.
• Support maintenance activities for existing product lines and quality systems.
• Collaborate cross-functionally to improve product quality and compliance standards.

Requirements

• Bachelor's degree in engineering (B.E./B.Tech or equivalent).
• 13 years of experience in the Medical Device industry.
• Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements.
• Experience in complaint handling, investigations, and root cause analysis.
• Familiarity with CAPA processes and quality systems.
• Strong analytical and problem‑solving skills.
• Experience with statistical tools/software such as Minitab is a plus.
• Ability to read and interpret technical drawings and engineering documentation.
• Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases.
• Ability to manage multiple tasks and projects effectively.

Preferred Experience

• Experience with ANSI/ISO/ASQC standards.
• Exposure to continuous improvement methodologies and process controls.
• Knowledge of medical device regulatory environments and compliance practices.

Work Environment

• FDA-regulated manufacturing environment.
• Temperature and humidity‑controlled workspace.
• May require use of static‑protective equipment while in designated work areas.

Physical Requirements

• Ability to sit for extended periods.
• Good hand‑eye coordination and dexterity.
• Ability to lift up to 40 lbs when required.