Job title:Quality Assurance Associate
Location:Bishopstown, Cork.
Benefits:Excellent salary, 10% bonus, hybrid working, healthcare and pension.

Company:
My client, spun out from Munster Technological University (formerly Cork Institute of Technology) in 2015, develops innovative ENT (Ear, Nose, and Throat) medical devices that simplify surgical procedures by enabling treatments to be conducted safely outside the operating room—typically with just topical anesthesia.

Role:
You will be responsible for assisting in the maintenance of the Quality Management System (QMS), assist with the management of internal processes and external vendors to ensure product quality. This involves managing supplier relationships, participating in audits, resolving quality issues, driving continuous improvement initiatives and collaborate with various teams to maintain quality across the supply chain. The person in this position must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry.

Job Requirements:

• Maintaining the effectiveness of the QMS and making continuous improvements to it.
• Managing day-to-day QA activities including frequent interface with contract manufacturers, QA consultants and testing contractors as well as handling multiple projects related to product and compliance enhancements.
• Responsible for assisting in notified body audits and internal audits.
• Maintain and coordinate quality system schedules, including: Supplier and internal audits; management review and documentation updates.
• Support the wider team to ensure product manufacture and testing meets the requirements.
• Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting audits to ensure compliance with quality standards.
• Investigating, analysing, and resolving any product quality problems, including root cause analysis and implementing corrective and preventive actions.
• Ensuring that incoming materials meet the required specifications and working with the engineering team to address any quality concerns.
• Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to:
• coordinating investigations between complainants and contract manufacturing sites
• follow up on corrective actions, when required
• Support with Significant Changes and Notified Body interactions.
• Carry out other quality related duties as required, inclusive of updates to procedures, forms, processes and periodic reviews.

• Bachelor’s degree in engineering or science. Quality certification in ISO 13485 a must.
• A minimum of 4 years of experience in a medical device QA position(s) role within a medical device organisation.
• Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR and 21 CFR Part 820.
• Desirable to have lead auditor certification and/or Regulatory certifications.
• Proven track record with the ability to successfully manage projects to deadlines.
• Good Documentation Practice experience.
• Report & Technical Writing experience.
• Project Management experience.
• Strong ability to manage critical projects as part of an interdisciplinary team.
• Excellent problem solving and communication skills.