Quality Assurance Specialist GFCA

Responsible for supporting the Global Field Corrective Action (FCA) function.

• 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

• 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)

• 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

10 %.

Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community. If you require accommodation and support to apply for a position, please contact us at . Diversity fosters innovative thinking and entrepreneurship and that's what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in. Our approach is simple, we embrace everyone and want them to feel they belong here. We are building a culture where all employees can bring their best and unique selves to work. If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.