Quality Engineer
Axelon
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.
- 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.
- 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.
Vacancy posted 4 days ago
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