Quality Engineer

Katalyst CRO; Dexter (MI); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

Katalyst CRO in Michigan is seeking a Quality Complaint Investigation professional to support complaint investigations, CAPA activities, and continuous improvement in a regulated medical device environment. The role involves analyzing quality data, performing root cause analyses, reviewing GMP documentation, and ensuring compliance with FDA QSR 21 CFR 820.

You will collaborate cross-functionally, prepare investigation summaries, and drive corrective actions to improve product quality and

Formación

• Bachelor's degree in engineering (B.E./B.Tech or equivalent).
• Experience in the Medical Device industry and FDA QSR knowledge preferred.
• Familiarity with CAPA processes and quality systems.
• Experience in complaint handling, investigations, and root cause analysis.
• Proficient in MS Office and ability to read engineering docs.

Responsabilidades

• Review customer complaints and service data to determine risk levels and codes.
• Conduct complaint investigations and perform root cause analysis.
• Analyze data from quality systems to identify trends and issues.
• Prepare investigation summaries, reports, and recommendations.
• Review investigation reports for GMP compliance gaps.
• Support development and implementation of CAPA.
• Drive continuous improvement and process control activities.
• Conduct data analysis using statistical tools and quality methods.
• Collaborate cross-functionally to improve product quality and compliance.

Conocimientos

Analytical thinking

Problem solving

Statistical tools (Minitab)

CAPA processes

Engineering documentation reading

MS Office (Excel/Word/PowerPoint)

Data analysis

Educación

Bachelor's degree in engineering or equivalent

Herramientas

Minitab

Quality management systems software

Descripción del empleo

Job Description

We are seeking an Quality Complaint Investigation 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

• 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.

Job Description

We are seeking an Quality Complaint Investigation 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.