Post-Market Quality Engineer: Data-Driven Insights

Katalyst CRO; Covington (GA); In loco; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Client Urology & Critical Care (UCC) seeks a Quality Engineer I for Post-Market Surveillance to manage PMS data, write review summaries, and drive documentation updates. The role involves cross-functional collaboration with Quality, R&D, Regulatory, Clinical Affairs, Marketing and Operations to ensure timely, compliant PMS deliverables.

The position requires a B.S. in a relevant field and 1–3 years in a regulated industry; ASQ certifications are a plus.

Competenze

• 1–3 years of quality experience in a medical device or pharma or other regulated industry.
• American Society of Quality (ASQ) certification(s) (CQE, CQA, etc.) preferred

Mansioni

• Ensures PMS activities are completed on time and in compliance with laws, regulations and procedures.
• Compile PMS data from multiple sources and prepare summary reports of marketed products.
• Drive updates to product documentation to address gaps found during PMS review.
• Update PMS processes and related documentation as needed.
• Collaborate with Quality, R&D, Regulatory, Clinical Affairs, Marketing and Operations to complete PMS reviews.
• Escalate issues to management when needed and ensure proper risk-based decisions.
• Support knowledge sharing on product risk management and regulatory standards.

Conoscenze

Data analysis

Report writing

Cross-functional collaboration

Attention to detail

Time management

Communication skills

Problem solving

Statistical techniques

Formazione

B.S. in Engineering/Science/Math

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Descrizione del lavoro

Client Urology & Critical Care (UCC) seeks a Quality Engineer I for Post-Market Surveillance to manage PMS data, write review summaries, and drive documentation updates. The role involves cross-functional collaboration with Quality, R&D, Regulatory, Clinical Affairs, Marketing and Operations to ensure timely, compliant PMS deliverables.

The position requires a B.S. in a relevant field and 1–3 years in a regulated industry; ASQ certifications are a plus.