Engineer II (Quality/PMS) - 8909030
- Irvine, California
- Pharma & Biotech, Medical Devices, Quality & Supply Chain, Engineering & Validation, Quality Assurance (QA), Quality Assurance (QA), Operations, R&D, Regulatory Affairs (RA)
One of my top Class III Medical Device clients is currently looking to bring on an "Engineer II - Quality /Post Market Surveillance" and will be responsible for activities associated with the implementation of EU Medical Device Regulation (MDR) Program.
This person 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.
- 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.
- 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
- 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
The client is ready to interview immediately, so if you're interested in applying - please submit your updated resume in word format!
Sthree US is acting as an Employment Business in relation to this vacancy.