Quality Assurance Specialist GFCA, Athlone

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

Responsibilities

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

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 Travel Required 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.

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