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- Irvine, CA
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Engineer II (Quality/Post Market Surveillance)
Apex Systems • Irvine, CA
Posted 5 days ago
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Global medical device company in Irvine is seeking a Quality Engineer II specializing in Post-Market Surveillance.
- 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
- 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
Education and Experience:
- Bachelors 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.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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