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Engineer II (Quality/Post Market Surveillance)

Ascent Irvine Contractor
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Job Req #: 19-06400
Job Description: Post Market Surveillance Quality Engineer II
Location:  Irvine, CA
Position Type: 6+ Months
Position Summary:
The Post Market Surveillance Quality Engineer II will provide engineering support for PMS system to collect and perform trend analysis assessing the following data sources on products: adverse events, complaints, product feedback, customer requirements and market needs, patient follow-up after clinical trials/investigations, service reports, scientific papers in peer-reviewed journals, reports on similar products by competitors, Field Corrective Action, CAPA, Client and SCAR review and changes to relevant standards and regulations.

Key Responsibilities:
  • This would include usability engineering plan, review of and evaluation of historical data and summative evaluation plan.
  • Conduct and support the Post-Market Surveillance activities to ensure compliance to EU Medical Device Regulation (MDR) requirements,
  • Provide quality engineering expertise in the areas of Risk Management, Design Controls, Usability Engineering, Quality Assurance/Control, Regulatory Compliance, and Statistical Techniques, as needed.
  • Ensure compliance with all Federal, State, local and company regulations, policies and procedures
  • Highly organized and drive project plans per timeline
  • Ability to effectively analyzing data and report data with large datasets is required
  • Effective communication and presentation skills
  • Strong statistical analysis skills using excel
  • Must have experience in medical device industry

  • A Bachelor’s Degree or equivalent in Engineering field with a minimum of three (3) years of related experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries.
  • Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
  • Proven expertise in MS Office Suite and ability to operate general office machinery
  • Excellent written and verbal communication skills and interpersonal relationship skills Demonstrated problem-solving, critical thinking, and investigative skills
  • Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
  • Good knowledge of medical terms and human anatomy
  • Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
  • Ability to manage confidential information with discretion
  • Attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Work is performed independently on complex work and reviewed for accuracy and soundness
Brierly Lindberg
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