Position: Quality Engineer II - Post Market Surveillance, Req#: 9807723 Location: Irvine, CA Duration: 6+ Months
Education and Experience:
A Bachelor’s Degree and equivalent in Engineering field with a minimum of 2-4 max years of related experience dealing with regulatory or quality assurance issues in the medical device or pharmaceutical industries.
Candidate must have intermediate excel skills including vloopups, pivots, formulas
Candidate must have an understanding of statistics
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 the 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 client 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 complain 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
Duties: The Post Market Surveillance Quality Engineer I 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, NCR and SCAR review and changes to relevant standards and regulations. This PMS Quality Engineer will also be focused on activities associated with the implementation of the EU Medical Device Regulation (MDR) Program.
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