Engr 2, Quality

TechDigital Group; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

TechDigital Group is seeking a Quality Engineer I to support Post-Market Surveillance (PMS) for medical devices. You will help ensure timely, compliant PMS activities and data-driven reports across Quality, R&D, Regulatory, Clinical Affairs, Marketing, and Operations.

Responsibilities include reviewing data sources, writing summaries, and driving updates to product documentation while aligning with ISO 13485:2016, FDA QSR, EU MDR, and related standards.

Qualifications

• Proficient in writing detailed summary reports and data analysis for conclusions.
• Excellent verbal, written, and presentation communication skills.
• MS Office proficiency including Word, Excel and PowerPoint.
• Able to manage multiple tasks concurrently and in cross-functional settings.
• Knowledge of product risk management and global regulatory standards.
• Basic statistics techniques and data interpretation.

Responsibilities

• Ensures PMS activities are completed on time and in compliance with laws and procedures.
• Compile PMS plans and reports from multiple data sources and summarize findings.
• Drive changes to product documentation based on PMS reviews.
• Update PMS processes, documentation, and related procedures as required.
• Coordinate with Quality, R&D, Regulatory, Clinical Affairs, Marketing and Operations.
• Escalate issues to management as needed and ensure regulatory alignment.

Skills

Report writing

Data analysis

Communication skills

MS Office

Multitasking

Cross-functional collaboration

Risk management basics

Regulatory knowledge

Statistics basics

Education

BS in Engineering / Science / Mathematics

ASQ CQE / CQA certification

Tools

Microsoft Word

Microsoft Excel

Microsoft 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).

Job 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.

Education and Experience

Required:

• 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.)

Knowledge and Skills

Required:

• 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