Sr. Quality Engineer

Job Summary:

The Senior Quality Engineer will be responsible for the documentation, oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure in a timely manner and in accordance with Senseonics procedures. They also will communicate with Regulatory, Clinical, Engineering, Manufacturing, Sales, Customer Support, and other functional experts as needed to ensure clear understanding/investigation of applicable issues.

Duties and Responsibilities include, but are not limited to:

• Review and evaluate all possible feedbacks received by Senseonics to identify whether a Senseonics customer complaint has been made.
• Responsible for processing complaints and incident reports for submission (MDR and Vigilance) to assure that complaints are documented, reviewed, evaluated, investigated, reported if applicable, and formally closed in a timely manner.
• Establish and maintain complaint files and databases for all customer complaints in accordance with U.S. and international regulations.
• Coordinate with Customer Service, Engineering, Quality, and any complaint investigation and analysis personnel to gather root cause determinations and properly document complaint closure.
• Possible involvement with and/or support of internal and external audits of activities related to handling and documenting customer complaints.
• Maintain an understanding of information/data required to be collected for technical and AE complaints to assure compliance with regulations and directives.

Knowledge, Sills, Abilities and Requirements:

• Working knowledge of 21 CFR 820, 21 CFR 803, ISO-13485, ISO-14971, MEDDEV Vigilance Guidance
• The candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
• Excellent computer skills, including Outlook, Word, Excel, and Powerpoint
• Experience in a GMP and/or ISO regulated environment is preferred.
• Ability to learn various and multiple software programs
• 3+ years of experience in a medical device complaint handling documentation & processing preferred.
• Ability to work in a cross-functional environment required.
• Bachelors in Engineering or a Scientific field desired.