Audit Project Manager- Healthcare
Audit Project Manager- Healthcare Start ASAP 6 months- 1 year contract Bellevue, WA Job Description Our team is a medical device manufacturer subject to regulation by the Food and Drug Administration (FDA) and its international counterparts. In order to meet their regulatory obligations, the team has implemented a quality system, including information governance components for security and privacy. The team is working with its stakeholders and corporate partners to maintain and continually update this system. Looking for a technical PM to engage internal and external entities to help maintain and improve upon our TFS and SharePoint backed Quality System as well as assist in improving quality procedures and documentation/training. Project: The duration for this position will most likely be for the upcoming year, although we may start out with a 6 month engagement. Not 100% sure on that. Hours are typical (40/week). The two key goals for this project are: ensuring that HealthVault is compliant with regulatory requirements, and implementing a system and related workflows that provide value (agility, compliance, etc.) to the business. The vendor would be working with a cross-functional team to maintain and update a system that meets these two requirements. Required Skills: Prior technical program management experience Strong technical skills, including ability to manage technical issues related to integrating multiple SQL-based systems and Visual Team Foundation Server Experience in implementing process workflows into software requirements Experience with Microsoft applications such as MS SharePoint, Excel, PowerPoint and Word preferred Prior experience in medical device regulatory affairs a plus; preferably including quality system and training Prior experience in information governance a plus; preferably including ISO 27001 certification experience Experience with Source Control is preferred Must be Detail orientated and have good communications skills Team Foundation Server (TFS) preferred Compliance and auditing experience required TFS document control is nice to have Previous Client experience is nice to have Previous experience with Document control procedures nice to have Document analysis experience is preferred About our client: The Software Giant, headquartered in Redmond, Washington is looking for top talent local to the Puget Sound area! If you are interested in being part of the latest and greatest in technology and being part of cutting edge solutions, this is the place for you! If you have previous experience working for the Eastsides largest software company in the past, we want to talk with you! Please email your resume to email@example.com referencing the appropriate Job ID [J-10-681-219]. Phone calls are also welcome: 425-516-9100. Must have proof of eligibility to work in the United States Referrals are welcome!
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