A large, global medical device company in Irvine has an opportunity for an Engineer l with Post Market Surveillance experience. Essential Job Functions:
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
Education & Experience
- 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
- 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 company 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
- Bachelor's degree or equivalent in Engineering Field
- Minimum of 1-2 years 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
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Education & Experience
• Bachelor’s degree or equivalent in Engineering Field
• Minimum of 1-2 years 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
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