Engr 2, Quality

Katalyst CRO; Covington (GA); On-site; USD 70,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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

Responsibilities

• 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.

Skills

Data analysis

Report writing

Cross-functional collaboration

Attention to detail

Time management

Communication skills

Problem solving

Statistical techniques

Education

B.S. in Engineering/Science/Math

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Job Summary

A Quality Engineer I in Post-Market Surveillance is responsible for executing and coordinating the day-to-day operations of the post-market surveillance program and related processes. The primary tasks of this role include reviewing various data sources to write summary reports of marketed products. Additionally, this position's scope includes executing various quality engineering tasks in support of the quality department. The PMS Quality Engineer will thrive in analyzing and summarizing various data sources and in cross functional interactions with Quality, R&D, Regulatory, Clinical Affairs, Marketing, and Operations to complete projects and reports. The PMS Quality Engineer will operate within a mature quality system that follows FDA regulations, ISO regulations, MDR regulations, and international regulations that apply to products manufactured by Client Urology & Critical Care (UCC).

Responsibilities

• Ensures post-market surveillance (PMS) activities are completed on time and in compliance with applicable laws, regulations, and company procedures.
• Responsible for post-market surveillance plans and reports including the compilation of data from various sources, analysis of the data, accurate representation of the product's post-market review, and summary of findings.
• Responsible for driving changes to product documentation to fill gaps discovered during the post-market surveillance review.
• Performs changes to the PMS process (including practice, procedure and associated documentation) as required.
• Coordinate and collaborate with Quality partners, R&D, Regulatory, Clinical Affairs, Marketing, and Operations to facilitate completion of the PMS Review process and builds productive multi-functional working relationships.
• Ability to discern when issues are to be raised to management for resolution.
• Ensures compliance to company procedures, external laws, and regulations when performing tasks.

Requirements

• B.S. in Engineering, Science, or mathematics field.
• 1-3 years of Quality experience in a medical device or pharma or other regulated industry.

Preferred

• 1-3 years experience in Post-Market Surveillance in the medical device industry
• American Society of Quality (ASQ) certification(s) (CQE, CQA, etc.)

Required

Knowledge and Skills

• Proficiency in writing detailed summary reports and experience in analyzing data to draw conclusions for reports.
• Proficient communication skills (verbal, written and presentation).
• Proficiency with Microsoft Suite of Products (Word, Excel, PowerPoint, etc.).
• Effective listening, questioning, problem solving, conceptual thinking, and analytic skills.
• Ability to manage multiple assignments and projects concurrently.
• Ability to participate in a cross-functional team environment and exercise influence to effectively collaborate and complete deliverables on time.
• Basic understanding of product risk management and related deliverables (Risk Management Plan, Failure Mode and Effect Analysis, Benefit-Risk Analysis, Risk Management Report, etc.).
• Basic knowledge and understanding of appropriate global regulations, requirements, and standards such as ISO 13485:2016, FDA Quality System Regulation, EU Medical Device Regulation (EU) 2017/745, SOR/98-282 Medical Device Regulations (Health Canada), ISO 14971:2019.
• Basic knowledge of statistical techniques.

Preferred

• Strong attention to detail.
• Proficient understanding of product risk management.
• Ability to operate efficiently, proactively and effectively.
• Advanced problem-solving skills.