Quality Engineer - Post Market Surveillance - Medical Device

Quality Engineer

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 Mathematics. Preferred certifications American Society for Quality (ASQ) certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) preferred. Required 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 2019. Soft 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 skills. Responsibilities 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.**