To begin the application process, please enter your email address.
Company Contact Info
- Irvine, CA
Sorry, we cannot save or unsave this job right now.
Report this Job
Saving Your Job Alert
Job Alert Saved!
Could not save Job Alert!
You have too many Job Alerts!
This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.
Email Send Failed!
Engineer I (Quality/ Post Market Surveillance)
Apex Systems • Irvine, CA
Posted 11 days ago
Get facts about other applicants with a CareerBuilder Account
Global medical device company in Irvine is seeking Quality Engineers to join their team!
- 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 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
- A Bachelors Degree or equivalent in Engineering field with a minimum of 1-2 years of related experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178