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Rose International
Quality Engineer - Post Market Surveillance - Medical Device
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Job Description
- Only qualified Quality Engineer candidates located near the Covington, Georgia area will be considered due to the position requiring an onsite presence: 4 days in the office and 1 day remote
- Required Education
- Bachelor's in Engineering Science or MathematicsPreferred Certifications
- American Society for Quality (ASQ) certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) preferredRequired Experience
- 1 to 3 years of Quality experience in a medical device, pharmaceutical, or other regulated industry
- 1 to 3 years of Post Market Surveillance experience in the medical device industry Tech Skills
- Detailed summary report writing
- Data analysis and interpretation
- Microsoft Word Excel and PowerPoint
- Product risk management
- Risk Management Plans
- Failure Mode and Effect Analysis (FMEA)
- Benefit Risk Analysis
- Risk Management Reports
- Statistical techniques
ISO 13485 2016
- FDA Quality System Regulation
- European Union Medical Device Regulation (EU MDR) 2017/745
- Health Canada Medical Device Regulations
ISO 14971
2019Soft Skills- Strong verbal written and presentation communication skills
- Effective listening and questioning skills
- Problem solving and conceptual thinking
- Analytical skills
- Ability to manage multiple assignments and projects concurrently
- Ability to collaborate effectively in a cross functional team environment
- Ability to influence cross functional partners and complete deliverables on time
- Strong attention to detail
- Proactive and effective approach to work
- Advanced problem solving skillsResponsibilities
- Execute and coordinate daily Post Market Surveillance activities and related processes
- Ensure Post Market Surveillance activities are completed on time and comply with applicable laws regulations and company procedures
- Develop Post Market Surveillance plans and reports by compiling and analyzing data from multiple sources
- Accurately represent product Post Market Surveillance reviews and summarize findings
- Identify gaps during Post Market Surveillance reviews and drive changes to product documentation
- Perform changes to Post Market Surveillance processes practices procedures and associated documentation as required
- Coordinate and collaborate with Quality Research and Development Regulatory Clinical Affairs Marketing and Operations teams to complete Post Market Surveillance reviews
- Build productive cross functional working relationships
- Identify issues that require escalation to management for resolution
- Ensure compliance with company procedures external laws and regulations when performing assigned tasks
- Support quality engineering activities within the Quality organization
- Only those lawfully authorized to work in the designated country associated with the position will be considered.
- Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.