Quality Engineer 1
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POST DATE 9/16/2016
END DATE 11/8/2016
JOB DESCRIPTIONSuperior Group is looking for Quality Engineer 1 for our Client located in Berkeley, CA
The Quality Assurance Document Control coordinator is responsible for managing the Document Management System that complies with quality system requirements, for release of documents, Quality assurance approval of manufactured product materials/batch records/labels, and for supporting the training program for Clients Molecular Diagnostics.
The electronic controlled document management systems, including management of Quality Records, Design History Files, Engineering Change Orders, Design History Record reviews, and Batch/Raw material Release.
Final product lot release activities with scans of manufacturing executed batch records and raw material QA review acceptance.
Correspondence with appropriate stakeholders.
QA review of label documentation, verifies printed sample labels for correctness
Overseeing the archiving process and inventory listings for on-site and offsite records, retention and destruction of archived documents
Create, monitor, and administer the management of Purchase Orders for Document Control activities, including off-site storage.
Assists authoring and processing changes through the Change Control, ECO, and Document change notices supporting design changes, SOP changes and Manufacturing documents.
Reviews documents submitted to ensure the use of correct templates, types, training, and quality requirements prior to posting for release.
Review document changes and provide effective communications of changes for site awareness and to facilitate training requirements.
Administer and maintain compliant periodic review scheduling and reporting.
Administer and maintain records and number issuance for equipment and log notebooks.
Manages the numbering system, version numbers and effective date of all documents
Organizes, administers and oversees the maintenance of an electronic and hard-copy organizational structure for effective storage and retrieval of all documents
Serves as in-house expert on creation and closure of change controls
Strategize within Quality and cross-departmentally to assess effectiveness of current document control and training systems and processes and make recommendations and plans for improvements
Support the development of metrics and reports to assess the performance of Controlled Document
Provides support for internal and external audits pertaining to document management and document requests.
Administer system updates to the document control system as required and support training through system administration.
As the SME participate and collaborate with Business Units/departments to ensure QMS compliance and alignment of local SOP’s as required with common Business Unit SOP’s.
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
Experience working on a regulated Medical Device, IVDD or Parma environment
Experience with Design Control and manufacturing.
Experience with Quality Assurance approval of materials, labels, and Batch Records within a manufacturing environment.
Medical Device industry
Manufacturing environment in the medical field.
Experience with Lotus Notes Document Change and SAP document structures
Strong technical writing skills
Advanced software skills (including SharePoint, Acrobat Pro, Microsoft office, and SAP), and demonstrated troubleshooting and problem-solving techniques to work independently.
Ability to develop and present training materials to large groups, author and update controlled document procedures as needed
Proven ability to work under tight deadlines and pressure in a composed manner
Comfortable communicating with all levels of staff, including executives
Effective organization, communication, and team orientation skills
Project management skills prefers
On site management of the document control functions with the ability to travel as