Quality Assurance Specialist

ARKRAY, Inc.; Fingal; On-site; EUR 38,000 - 52,000; Full time

Job summary

ARKRAY Ireland Limited, a global healthcare company, is seeking a Quality Assurance Specialist to oversee QA activities for European operations. The role reports to the General Manager and involves managing the QMS, handling complaints and CAPAs, and ensuring regulatory compliance.

Ideal candidates hold a science/engineering degree with 1–2 years in QA, strong MS Office skills, and excellent communication. Experience with medical devices/IVDs and ISO 13485 is advantageous.

Qualifications

• Bachelor’s degree in Science, Engineering, or a related field.
• 1–2 years’ experience in Quality Assurance.
• Proficient in MS Office applications.
• Excellent communications skills.
• Detail-oriented with ability to multi-task.
• Experience in Medical devices/IVDs advantageous.
• Good team player who can work with minimal supervision.
• In-depth knowledge of ISO 13485 advantageous.

Responsibilities

• Support QA in implementing Quality Management standards aligned with global standards.
• 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 daily.
• Manage complaints and recall investigations and NCRs/CAPAs.
• Coordinate CAPA documentation and activities to meet deadlines.
• Oversee document and data control system compliance.
• Ensure compliance with Walmart, EMC, RoHS, WEEE, REACH regulations.
• Contribute to projects and other business duties as needed.

Skills

MS Office

Communication

Detail-oriented

Team player

Education

Bachelor's degree in Science/Engineering

Tools

ISO 13485 knowledge

Job description

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:http://www.arkray.co.jp/english/index.html