Quality Engineering Manager
Location: Dublin, Ireland Department: Quality Engineering
The Quality Engineering Manager – NPI will lead critical projects for new product introduction by providing leadership to a Quality Engineering Team of 5–7 associates. This role involves managing validation studies and collaborating with a wide range of internal and external stakeholders to ensure successful product launches.
Responsibilities
* Quality Systems Support: Ensure the organisation’s quality management system aligns with ISO 9000/ISO 13485 standards, essential within the medical devices and pharmaceutical industries.
* Regulatory Compliance: Oversee activities to ensure adherence to all applicable regulatory requirements.
* Leadership: Serve as a key member of the Quality Leadership Team, leading, mentoring, and managing the Quality Engineering Team through daily activities, performance reviews, and delegation.
* Continuous Improvement: Drive process enhancements and product quality improvements by supporting programs such as Six Sigma.
* Quality System Management: Oversee systems related to production support, including non-conformance management, incident reporting, and customer complaint analysis.
* Customer Interaction: Act as a liaison with external customers to ensure that quality standards align with client expectations.
* CAPA Management: Ensure Corrective and Preventive Actions (CAPAs) are effectively executed in compliance with regulatory requirements.
* GMP Oversight: Maintain Good Manufacturing Practice (GMP) compliance across Production and Quality Engineering functions.
* Documentation: Develop and maintain comprehensive documentation to meet all regulatory requirements.
Education & Experience
* Minimum of 5 years working within an ISO 9001/13485-regulated environment, preferably in medical devices or pharmaceuticals.
* At least 3 years in a supervisory or leadership role.
* Strong understanding of Statistical Process Control (SPC) and Six Sigma methodologies (Greenbelt Certification preferred).
* Advanced technical writing skills with experience in FDA requirements and audits.
* Background in process validation, sterilization, and cleanroom environments is highly desirable.
For further information on this Quality Engineering Manager role in Dublin please contact Caroline Kingston on +353 868395531 or email caroline@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/.
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