Quality Assurance Specialist GFCA

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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