Clinical Scientist

Job Title: Clinical Scientist / Post Market Quality Specialist

Location: Texas

Employment Type: Contract (W2 Only)

Job Summary

We are seeking a motivated Entry-Level Clinical Scientist / Post Market Quality Specialist to support post-market surveillance and quality activities for medical device products.

The ideal candidate will assist with complaint trend analysis, product investigations, post-market documentation, and regulatory compliance activities while collaborating with Quality, Clinical, and Regulatory teams.

Key Responsibilities

• Support analysis of complaint and post-market surveillance data to identify product trends and risks
• Assist with preparation and maintenance of:
• PMS Reports
• PSUR Documentation
• PMCF Documentation
• Participate in product investigations and support root cause analysis activities
• Assist with CAPA, deviation, and quality documentation activities
• Support Post Market Surveillance Review Board (PMSRB) meetings and documentation
• Collaborate with Quality, Clinical, and Regulatory teams to support compliance initiatives
• Ensure documentation complies with FDA, ISO 13485, ISO 14971, and EU MDR requirements

Required Qualifications

• Bachelor’s degree in Engineering, Biomedical Sciences, Life Sciences, or related field
• 0–2 years of experience in Quality, Clinical, Post-Market Surveillance, or medical device environments
• Basic understanding of:
• FDA Regulations
• ISO 13485
• ISO 14971
• Post-Market Surveillance processes
• Strong analytical, documentation, and communication skills
• Ability to work in cross-functional team environments

Preferred Skills

• Familiarity with complaint handling or CAPA processes
• Exposure to statistical analysis or trend reporting
• Knowledge of medical device quality systems and regulatory standards
• Experience with technical documentation or investigation support is a plus