Sr. Quality Engineer
- Expired: over a month ago. Applications are no longer accepted.
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.
ManufacturingView all jobs at Senseonics Incorporated
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