Quality Assurance Specialist

POSITION TITLE: Quality Assurance Specialist

TYPE OF EMPLOYMENT: Full-Time/ On-site

REPORTS TO: General Manager of ARKRAY Ireland Limited

Summary

ARKRAY is a global healthcare company that is contributing to the health and well-being of people all over the world through the discovery of new technologies. With over 65 years in business, our products are now being used in 80 different countries worldwide and still growing; especially in the European region where in the last few years we have established multiple sales offices and a distribution center. We are currently looking for an experienced and highly motivated Quality Assurance Specialist, who is looking to take on a new challenge and grow together. This position will be responsible for managing all QA activities to help develop our European operations.

Join us and build the future with ARKRAY!

Responsibilities:

• Support the business in managing and implementing Quality Management standards and processes that are aligned with the global standard and relevant to the local market nuances
• Write and manage SOPs.
• Participate in Internal and External audits as required.
• Participate in corporate risk assessments, primarily for ISO 13485
• Manage the QMS system on a daily basis.
• Manage complaints and recall issues as well as carry out the investigations.
• Manage NCRs and CAPAs for products as required.
• Coordinate the on-time completion of CAPA documentation and activities.
• Oversee the compliance of document and data control system.
• Comply with regulations such as Walmart, EMC, RoHS, WEEE, REACH.
• Contribute to projects and other business-related duties to meet business needs.

Qualifications:

• Bachelor’s degree (ordinary or honours) in Science, Engineering, or a related field
• 1 to 2-years’ experience in Quality Assurance
• Proficient in MS office applications
• Excellent communications skills
• Detail-oriented with the ability to multi-task
• Experience in Medical devices/IVDs will be an advantage
• Good team player who can work efficiently with minimal supervision
• In-depth knowledge of ISO 13485 will be an advantage
• Location: ARKRAY Ireland Limited
• Unit C, North Dublin Corporate Park, Swords, Co. Dublin K67 P6D3, IRELAND

For more information about our company and products, please visit our website: