Job Description
Position Summary
Responsible for supporting the Global Field Corrective Action (FCA) function.
Principal Responsibilities
Key responsibilities will include (but are not limited to) the following:
• Supporting the FCA team in the execution of Field Corrective Actions
QARA
• Scheduling, hosting calls with cross functional teams and senior levels of leadership in the absence of FCA
management, minute taking and distribution
• Data maintenance, logging, reporting and filing
• Global mailbox management and escalation
• Competent Authority query logging, tracking and responses
• FCA file compilation and closure
• Establish, follow, and improve corporate, department, and other company procedures.
• Support other activities in the post-market surveillance function as it develops
Education / Experience Requirements
• Knowledge of Quality and Regulatory requirements and regulations including but not limited to FDA’s 21 CFR
• Part 820 (Quality System Regulation), ISO 13485 Quality System requirements, Council Directive 93/42/EEC
• (Medical Device Directive), MEDDEV, Canadian Medical Device Regulations, Japanese JPAL
• Minimum 3-5 years working experience in a similar environment
• Proven ability to work in a team
• Attention to detail and accuracy – essential
• Ability to communicate clearly
• Ability to work well under deadlines and pressure, and to prioritize tasks and interface with all levels of management
• Skills that enable coordination of data, including MS-Office (primarily Excel, PowerPoint, Word, and Outlook)
Specialized Skills / Other Requirements
Behaviours / Values
• Approachable and enthusiastic. Flexible and adaptable
• Excellent organizational skills with cultural awareness and sensitivity
• Able to work on own initiative and as a team player
• Ability to work well under deadlines and pressure, and to prioritize tasks and interface with all levels of
management
• Skills that enable coordination of data, including MS-Office (primarily Excel, PowerPoint, Word, and Outlook)
• Good judgment and problem-solving ability & can understand the impact of decision making on both Teleflex
Medical and their customers
• Able to build good, strong and positive working relationships with cross functional teams across Regions and Functions
• International & America’s QA/RA
• Global Manufacturing and Quality Teams
Key Relationships / Interfaces
• Quality Engineer, Global FCA
• Manager, Global FCA
• VP QA/Director level
TRAVEL REQUIRED: 10 %.
WORKING ENVIRONMENT:
☐ Office/Professional (Hybrid)
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