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MDR - Quality Engineer
Ref No.: 18-13519
Location: Northridge, California
Start Date / End Date: 11/05/2018 to 05/03/2019
Job Description:

Top things manager is looking for.

1.Experience in medical device industry
2.Experience and Knowledge of IEC 60601 series of technical standards.
3.Working knowledge of other standards related to medical devices – 62366, 62304, 14971

Position Description:
• Work with Standards Compliance Engineers to conduct gap assessments for products aiming to achieve European Union (EU) Medical Device Regulations (MDR).
• Convert existing EU Medical Device Directive (MDD) trace matrices to MDR matrices. Identify gaps where a trace does not exist.
• Create new EU MDR trace matrices for existing and for new products.

Basic Qualifications:
• Bachelor of Science degree in an Engineering or Science-related field with 2 years’ experience,
• Masters of Science degree in an Engineering or Science-related field.
• Experience translating standards into company requirements.
• Fluent in the use of MS Excel, MS Word, MS Windows OS.

Desired Qualifications:
• More than 4 years’ related experience in Quality Assurance and/or Quality Engineering in a regulated environment.
• At least 2 years’ experience within the medical device industry.
• Working knowledge of EU Medical Device Directive or equivalent and relevant international standards.
• Knowledge of IEC 60601 series of technical standards.
• Hands on experience in standards compliance tools and methodologies, including compliance gap assessments, checklists and essential requirements matrices.
• Good understanding of medical device product development processes.
• Self-starter and accountable, with sharp focus on quality and customer experience.
• Excellent verbal and written communication
• Ability to perform work with minimal supervision.

Physical Demands:
• The physical demands of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.