Quality Assurance Lead

2 weeks ago


Galway, Galway, Ireland Life Science Recruitment Full time

Company Overview

Lifescience Recruitment is an indigenous Irish medical device company committed to delivering high-quality products and services. We are currently seeking a Quality Assurance Lead to join our team.

About the Role

We are looking for a highly experienced professional to lead our quality assurance agenda, ensuring that we meet customer requirements for products and services as well as regulatory compliance in target markets. The successful candidate will have a proven ability to lead continuous quality improvement based on performance measurement and ensure adequate control of design activity to ensure product quality.

Main Responsibilities

Lead the company-wide quality assurance agenda to ensure regulatory compliance in target marketsEnsure the effective functioning of continuous quality improvement based on performance measurementImplement and maintain a certified Quality Management System to ISO13485 and FDA requirementsManage the QA team to ensure the proactive delivery of departmental objectivesRepresent the quality department in all NPI/NPD activities to ensure compliance with international quality and regulatory requirements

Requirements

To be successful in this role, you will need:

Key Qualifications

University Degree or a Post Graduate qualification in Quality Assurance or a related field8+ years of experience in Medical Devices or other similar regulated industrySignificant regulatory affairs experience including experience of international regulatory processesIn-depth knowledge of maintaining a certified Quality Management SystemProven leadership skills and excellent verbal and written communication skills

What We Offer

We offer a competitive salary and benefits package, including:

Benefits

Opportunity to work with a leading medical device companyChance to develop your career in a dynamic and growing industryCompetitive salary and benefits package

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