Sr. Quality Manager/Quality Manager
- Employer
- Perkin Elmer
- Location
- Waltham MA US
- Closing date
- Jul 7, 2017
View more
- Sector
- Science, Computer Science and IT
- Hours
- Full Time
- Organization Type
- Corporate
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JOB PURPOSE:
Responsible for overseeing post market surveillance, adverse events and recalls for Diagnostics. Manage and oversee global initiatives as they impact the Diagnostics organization.
This person is responsible for communicating with the FDA for recalls, MDRs, periodic updates, etc.. They will also be responsible for coordinating with the sites and IT to ensure that projects are appropriately prioritized, resourced and held to schedule. Additionally, the role will be responsible for Quality oversight of regional offices (Mexico, APAC, Akron, Waltham).
This position reports to the Director, Quality and Compliance for Diagnostics.
DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS:
Partner with Diagnostics Senior Management and local Site Management to facilitate post market surveillance across manufacturing sites. Partner with cross functional team members to drive quality improvement activities and lean priciples within the organization.
Responsible for overseeing post market surveillance, adverse events and recalls for Diagnostics. Manage and oversee global initiatives as they impact the Diagnostics organization.
This person is responsible for communicating with the FDA for recalls, MDRs, periodic updates, etc.. They will also be responsible for coordinating with the sites and IT to ensure that projects are appropriately prioritized, resourced and held to schedule. Additionally, the role will be responsible for Quality oversight of regional offices (Mexico, APAC, Akron, Waltham).
This position reports to the Director, Quality and Compliance for Diagnostics.
DUTIES AND RESPONSIBILITIES / ESSENTIAL FUNCTIONS:
Partner with Diagnostics Senior Management and local Site Management to facilitate post market surveillance across manufacturing sites. Partner with cross functional team members to drive quality improvement activities and lean priciples within the organization.
- Serve as the Diagnostics expert on post market surveillance activities, ensuring sites are supported through the decision making activity, closure, and termination of issues.
- Assist in establishing robust and consistent evaluation methodology ensuring reporting of adverse events are consistenly applied across all Dx sites.
- Function as the Subject Matter Expert on post market surveillance matters.
- Drive continuous improvement and LEAN activities with the sites to improve efficiencies in post market activities.
- Function as the Dx champion for IT projects impacting the Quality function and/or systems.
- Oversee the Akron Quality team ensuring that all feedback mechanisms are captured and addressed in a timely maner.
- Provide quality support for the Dx service organization and partner with local sites for improvement activities.
- Manage regional quality managers in Mexico and APAC to suppor the Dx business.
- Oversee Waltham quality activities related to R&D as well as CCMS.
- Ownership responsibility for the Dx business level QMR, establishing and disseminating metrics applied across all sites.
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