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The Project Coordinator (PC) in the Device Development Busniess Operations team will play a key role to support quality compliance and inspection readiness by executing responsibilities to enable the Device Development group comply with quality system requirements and support the maintainence of commercial products. The primary responsibilities of the PC are to facilitate effective execution of activities related to commercial product annual reviews and ongoing support, support internal quality audits and inspection, manage department training assignments and monitor completion, oversee the implementation of new processes and manage continuous improvments iniatives.
Project Planning and Execution:
Plan strategy and manage execution of commercial products annual product reviews conducted within the Device Development Group.
Support commercial product maintainance activities (eg changes and descrepancies) as needed.
Maintain project repository sites, contacts, and quality system documentation (eg. DHF).
Create tools as needed for continuous project management improvement and tracking
Interface with external functions appropriately for activities such as data collection, facilitating review meetings, generation of deliverables, and document approvals.
Schedule and facilitate team meetings and monitor action items to closure.
Develop and adapt project communication tools to drive awareness of project progress and risks across stakeholders including external collaborators
Liaises with other Teams to manage cross-functional activities and issues and risks
Effectively facilitates Team meetings with meaningful desired outcomes, appropriate participants, minutes, actions and follow up
Establishes centralized Team access to all relevant project information
Manages Team controlled document repository (e.g. Design History File)
Continuous Improvement Initiatives:
Leads business process continuous improvement initiatives through applying project lessons: business process updates, PM tool optimization & implementation, best practice sharing and driving awareness across teams.
Quality System Compliance for Device Development:
Manage the creation of training plans and make assignments to department employees and contractors. Monitor completion of training by sending notices of overdue training to indviduals and management.
Supports implementation of new and modified quality system processes to comply with Roche Pharma Quality Policy and Pharma Quality System (PQS) as well as Health Authority regulations.
Supports internal audits and inspections activities such as planning, backroom document support and corrective action correspondence.
Assist with resolving issues from internal quality assessments/audits, regulatory inspections and notified body interactions. Aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions
At least 5 years of experience with document management and quality compliance experience in the medical device or combination products industry.
Strong computer skills (MS Word, Excel, PowerPoint, Adobe Acrobat Pro) required
Familiar with FDA 21 CFR 820 and ISO 13485 as applied to design and development records
Project Management best practices: communication, scheduling, budget & resource planning, team building and risk management
Proficient with advanced usage of Electronic Document Management System (eg FirstDoc)
Software tools: Microsoft Office (Project & Excel), Google, WebEx, Visio
Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment
Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building) required
Ability to effectively communicate in a highly matrixed organization and with external parties
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