Job Title: Quality Engineering Manager - NPI
Location: South Dublin, Republic of Ireland
Description:
This role is responsible for leading critical projects for new product introduction at the plant. This involves providing leadership to the Quality Engineering team and managing validation studies, with a focus on ensuring compliance with regulatory requirements.
Key Responsibilities:
* Supporting the company's quality management system in accordance with ISO 9000/ISO 13485 standards.
* Ensuring regulatory compliance, including audits and inspections.
* Leading the Quality Engineering Team through daily management, performance reviews, and delegation.
* SUPPORTING CONTINUOUS IMPROVEMENT INITIATIVES TO ENHANCE PROCESS AND PRODUCT QUALITY.
* OVERSEEING SYSTEMS RELATED TO PRODUCTION SUPPORT, INCLUDING NON-CONFORMANCE, INCIDENT REPORTING, AND CUSTOMER COMPLAINT ANALYSIS.
* LIAISING WITH KEY EXTERNAL CUSTOMERS TO ENSURE QUALITY STANDARDS MEET CUSTOMER EXPECTATIONS.
* ENSURING CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS) ARE COMPLETED IN COMPLIANCE WITH REGULATORY STANDARDS.
* ENSURING GOOD MANUFACTURING PRACTICE (GMP) COMPLIANCE IN PRODUCTION AND QUALITY ENGINEERING ACTIVITIES.
* PREPARING AND MAINTAINING DOCUMENTATION TO MEET REGULATORY REQUIREMENTS.
Education & Experience Requirements:
* At least 5 years of industry experience, preferably in the medical devices or pharmaceutical industry.
* A minimum of 3 years in a supervisory role, indicating the need for leadership skills.
* Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous.
* Experience with FDA requirements and audits.
* Experience in process validation, sterilization, and cleanroom environments is a plus.