Design Control Lead
Principle Responsibilities (essential job duties and responsibilities):
- Thoroughly understands FDA and ISO Design Control requirements (i.e. FDA 820.30 , ISO 13485, ISO 14971) in order to lead the project team in translating the aforementioned regulations into project requirements
- Communicates and explains how the FDA and ISO requirements are incorporated into Acelity’s processes for project development and execution
- Manages all Design Control/Risk deliverables in accordance to Acelity processes with focus on timely approval and completion
- Briefs Innovation Lead/Project Manager with status updates including preparation for Stage Gate meetings.
- Works with Management during audit preparations for internal and external bodies
- Works with Acelity management to manage the overall Risk Management process, including the execution of Risk Panel and Harms and Hazard meetings
- Serves as the process and procedures authority on Design Control Processes and Design Control documentation management, including all associated Design Control Standard Operating Procedures (SOPs), Quality Procedures (QP), Work Instructions (WI), Forms, and Templates
- Works with the Design Control Analyst in maintaining “audit ready” DHF files
- Reviews draft test protocols, reports, and all other relevant documentation to ensure Good Documentation Practices have been followed; Acts as a liaison between approvers and author for questions/comments.
- Works with Management and team members to define/maintain adequate department procedures that promote accuracy, compliance, and lean business practices in accordance with global regulatory and company standards
- Serves as SmarTeam Support Coordinator including:
- Supports document management
- Assists project teams with research; exports information from SmarTeam into Excel for requestor to analyze
- Ensures project team members have been trained in SmarTeam by referring them to the Design Control Analyst
- Collaborates with the Project Manager to assign activities to the appropriate department
- Acts as the project meeting facilitator by leading each of the cross-functional groups in discussion. Keeps team focused on agenda, critical action items, and next steps.
- Ensures that Team Meeting Minutes including Design Reviews are captured and distributed (e.g., Action Items, High Level Critical Next Steps (Gantt Review led by PM), and Target Dates for Key Actions)
- Completes all project assignments within established schedules while maintaining consistently high standards of quantity and quality
- Utilizes existing supporting systems, including but not limited to Microsoft Office Applications, SMART DOC, SMART Team, I-Procurement, Oracle, etc.
- Assists other Design Control Leads in the execution of product development deliverables and overall project support
- Assesses and applies emerging technologies and best practices as they relate to Design Control
- Drives process improvements and value-added changes
- Works with management in the creation and execution of department metrics
- Performs research for Legal, Quality, and Regulatory associated with Intellectual Property, Litigation, Regulatory Submissions, and Quality/Compliance Issues.
- Provides audit support
- Bachelor’s degree in Business, Technical Writing, Quality, or other related field
- Minimum of 3 years in a mid to large corporate environment working with Project Management professionals
- Minimum of 3 years experience using Microsoft Office with a focus on Word and Excel
- Minimum of 3 years experience working in cross-functional groups
- Minimum of 1 year experience preparing technical documentation, or coordinating quality system documentation
- Ability to multi-task and appropriately prioritize and organize work, while maintaining attention to detail
- Strong written and oral communication skills
- Ability to communicate effectively, both verbally and in writing, to both technical and non-technical audiences
- Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service oriented attitude
- Previous experience in the medical device, pharmaceutical, or life science industries
- Experience preparing technical documentation or coordinating quality system documentation in medical product design and development