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Senior Quality Assurance Engineer / Regulatory Quality Coordinator [02/04/2010] |
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Principal Duties and Responsibilities
There are three aspects to this position. First, the Senior Quality Assurance Engineer / Regulatory Quality Coordinator will be responsible for ensuring our software is of very high quality. This will involve continuously iterating on our testing procedures to make them more and more comprehensive and effective. Our software involves tracking and leveraging information related to genetic variation. There are a very large number of different paths through our software. The successful applicant must have experience developing testing strategies for validating this type of software. It is important to note that this is a small team ¿ you will personally perform the bulk of the manual testing.
Second, the incumbent will serve as our regulatory quality coordinator. In this role s/he will ensure that our quality system is well maintained, constantly optimized to ensure a high quality product and consistent with FDA Good Manufacturing Practice regulations. This requires the ability to create and maintain numerous QA and regulatory documents and the capability to ensure the team stays within the guidelines of these documents and FDA regulations. The incumbent will also be responsible for maintaining product user guides.
Third, the incumbent will serve an important customer support function. This will include fielding customer service request, evaluating their severity from a quality perspective, monitoring the response and managing a strong relationship with external clients.
Required:
¿ Bachelors Degree Required: Computer Science Major preferred
¿ 5 years in information technology, minimum 2 years managing high complexity quality assurance efforts
¿ Minimum 2 years managing a 21 CFR 820 compliant quality system
¿ A desire and willingness to develop a deep understanding of the issues surrounding genetic testing. (However, prior knowledge in this area is not required.)
¿ Great communication and interpersonal skills
Any of the following would be a plus:
¿ Experience participating in an external and/or FDA 21 CFR Part 820 Audit
¿ Experience in an ISO 13485 setting
¿ Knowledge of genetics, genomics, or biological laboratory processes
¿ Knowledge of clinical processes / clinical systems
¿ Knowledge of: JavaSE/JavaEE, Eclipse, Shell and Perl Scripting, Ant, Linux
¿ Customer service experience Job Type: Permanent Location: Switzerland - Appenzell Ausserrhoden - Herisau / Trogen
Salary: [n/a] Date available: now Specialist Industry: Engineering Job Contact:: Contact Tel:: Interview Dates:: Closing Date:: Company: Partners Healthcare Company Description: Partners HealthCare is named among the nation's top 100 'Most Wired' health systems for 2009. Company Website: [n/a]
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05/16/2012