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Form of workJob Description
Battelle delivers when others cant. We conduct research and development, manage national laboratories, design, and manufacture products, and deliver critical services for our clientswhether they are a multi-national corporation, a small start-up, or a government agency.
We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.
We are currently seeking a Project Quality Specialist. This position located in Columbus, Ohio, and is focused on document control efficiency and effectiveness.
PRIMARY FUNCTION:
The Project Quality Specialist will provide project support to medical device product development teams and to Quality System leadership. This position requires the ability to implement quality processes and procedures on various product development projects, often medical device projects, as well as assistance in maintenance and improvement of an ISO 13485 compliant Quality System. This position includes the management of engineering documentation, including controlled documents and drawings, and maintaining project files using strong organizational skills. This position also includes development of standardized, compliant, efficient, and sustainable document management processes to support effective management across Battelles portfolio of medical products projects. The Project Quality Specialist works within a collaborative team environment. This position requires the individual to have strong computer skills, particularly with Microsoft Office (Word, Excel, and PowerPoint).
MAJOR RESPONSIBILITIES:
Serve as the site Subject Matter Expert for project documentation creation, review, approval, and control accountable for conformant document control, purchasing, and inventory control.
Manage document review, comment, and approval processes; manage and troubleshoot documentation workflows.
Drive and implement standardization and efficiency in internal documents (e.g. procedures, forms, templates, work instructions, and plans) and practices.
Review proposed changes to documents and assess compliance to document control processes.
Provide administrative project support to authors and process owners in formatting, writing, and revising medical device design history file documents and Quality System documents.
Ensure proper template usage and formatting. Format and edit documents, including Glossary, Standard Operating Procedures, Work Instructions, Specifications, and Forms to ensure compliance with appropriate standards and regulations.
Manage project file and process documents through the site document control system.
Monitor project conformance to the QS requirements and training compliance on project.
Participate in the records management and archiving processes.
Contribute to the resolution of exceptions (deviations, nonconformances, and CAPAs).
Maintain professionalism and collaboration with internal and external clients.
Contribute to training of staff for project specific software applications (e.g. Windchill)
Contributes to continuous improvement efforts across the organization.
THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:
Experience working in a regulated environment in document control systems and processes. Versed with records management practices.
Experience with the establishment and control of medical device design history files.
Versed with formatting of documents including tables, check box control, drop down boxes, etc.
Experience in electronic system process flows.
In-depth knowledge of and proficiency with Microsoft Office Suite.
Strong oral and written communication skills.
Excellent proof-reading skills.
Courtesy, tact, and effectiveness in dealing with people.
Passion for continuous improvement, quality, procedural compliance, and customer service.
Exceptional organizational, attention to detail and time management skills.
Ability to work independently and motivated to perform at a high-level without constant supervision.
THE FOLLOWING REQUIREMENTS ARE DESIRED TO BE CONSIDERED FOR THIS POSITION:
Bachelors degree preferred, in engineering or related technical field.
Desire candidate familiar in use of Windchill and Subversion.
We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.
We are currently seeking a Project Quality Specialist. This position located in Columbus, Ohio, and is focused on document control efficiency and effectiveness.
PRIMARY FUNCTION:
The Project Quality Specialist will provide project support to medical device product development teams and to Quality System leadership. This position requires the ability to implement quality processes and procedures on various product development projects, often medical device projects, as well as assistance in maintenance and improvement of an ISO 13485 compliant Quality System. This position includes the management of engineering documentation, including controlled documents and drawings, and maintaining project files using strong organizational skills. This position also includes development of standardized, compliant, efficient, and sustainable document management processes to support effective management across Battelles portfolio of medical products projects. The Project Quality Specialist works within a collaborative team environment. This position requires the individual to have strong computer skills, particularly with Microsoft Office (Word, Excel, and PowerPoint).
MAJOR RESPONSIBILITIES:
Serve as the site Subject Matter Expert for project documentation creation, review, approval, and control accountable for conformant document control, purchasing, and inventory control.
Manage document review, comment, and approval processes; manage and troubleshoot documentation workflows.
Drive and implement standardization and efficiency in internal documents (e.g. procedures, forms, templates, work instructions, and plans) and practices.
Review proposed changes to documents and assess compliance to document control processes.
Provide administrative project support to authors and process owners in formatting, writing, and revising medical device design history file documents and Quality System documents.
Ensure proper template usage and formatting. Format and edit documents, including Glossary, Standard Operating Procedures, Work Instructions, Specifications, and Forms to ensure compliance with appropriate standards and regulations.
Manage project file and process documents through the site document control system.
Monitor project conformance to the QS requirements and training compliance on project.
Participate in the records management and archiving processes.
Contribute to the resolution of exceptions (deviations, nonconformances, and CAPAs).
Maintain professionalism and collaboration with internal and external clients.
Contribute to training of staff for project specific software applications (e.g. Windchill)
Contributes to continuous improvement efforts across the organization.
THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:
Experience working in a regulated environment in document control systems and processes. Versed with records management practices.
Experience with the establishment and control of medical device design history files.
Versed with formatting of documents including tables, check box control, drop down boxes, etc.
Experience in electronic system process flows.
In-depth knowledge of and proficiency with Microsoft Office Suite.
Strong oral and written communication skills.
Excellent proof-reading skills.
Courtesy, tact, and effectiveness in dealing with people.
Passion for continuous improvement, quality, procedural compliance, and customer service.
Exceptional organizational, attention to detail and time management skills.
Ability to work independently and motivated to perform at a high-level without constant supervision.
THE FOLLOWING REQUIREMENTS ARE DESIRED TO BE CONSIDERED FOR THIS POSITION:
Bachelors degree preferred, in engineering or related technical field.
Desire candidate familiar in use of Windchill and Subversion.
