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.
• bility 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
• merican 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.
• bility to manage multiple assignments and projects concurrently.
• bility 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.
• bility to operate efficiently, proactively and effectively.
• dvanced problem-solving skills.