Quality Assurance Manager - Medical Devices

Quality Assurance Manager - Medical Devices

AbbVie

Sligo, Ireland

Job Description

An exciting role has opened up on our Ballytivnan site in Sligo. We are currently looking for a Quality Manager overseeing the Medical Device Quality team, reporting to the Quality Site Head. You will oversee the whole quality function for the medical device business on site. You'll ensure compliance with quality standards and regulatory requirements, leading a dedicated team of quality professionals.

Responsibilities

• Quality Assurance & Control: Oversee testing of raw materials, manufacturing quality control, and product validation;
• Team Leadership: Manage and lead a team responsible for compliance and quality oversight;
• Regulatory Compliance: Ensure adherence to corporate and regulatory requirements;
• Performance Reporting: Report on the performance of the quality management system to senior management;
• Issue Resolution: Timely resolution of quality issues and acting as a site representative during regulatory inspections;
• Budget Management: Assist in the development and administration of the quality department's annual budget.

Qualifications

• Essential: Bachelor’s degree in science/engineering and 5 years' experience in the healthcare/pharmaceutical industry;
• Desired: Master’s degree preferred;
• Experience: 6 years in Manufacturing/QA/R&D in relevant industries and 3 years in quality management;
• Skills: Familiarity with statistical quality systems, cGMP, and regulatory requirements. Strong leadership, communication, and interpersonal skills are necessary;
• Attributes: High attention to detail, commitment to quality, and integrity.