Quality Engineer

Summary:

Location: Covington, GA

Duration: 6 Months

Work Mode: 4 days onsite, 1 day remote

Responsibilities:

• Ensure 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.
• Drive changes to product documentation to fill gaps discovered during the post-market surveillance review.
• Perform 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 build productive multi-functional working relationships.
• Discern when issues are to be raised to management for resolution.
• Ensure compliance with company procedures, external laws, and regulations when performing tasks.

Requirements:

• B.S. in Engineering, Science, or Mathematics field.
• Minimum 1 year of quality experience in a medical device, pharma, or other regulated industry.
• 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 Skills:

• Minimum 1 year of experience in Post-Market Surveillance in the medical device industry.
• American Society of Quality (ASQ) certification(s) (CQE, CQA, etc.).
• Strong attention to detail.
• Proficient understanding of product risk management.
• Ability to operate efficiently, proactively, and effectively.
• Advanced problem-solving skills.