Quality Engineering Supervisor: Regulated Manufacturing Lead

Gazelle Global; Pomezia; On-site; EUR 65,000 - 90,000; Full time

Job summary

Gazelle Global is seeking a Quality Engineering Supervisor to lead the Quality team across manufacturing operations, ensuring product quality and regulatory compliance. You will oversee incoming inspection, non-conformance investigations, in-process quality control and final testing, driving data-driven improvements and CAPA programs.

You will collaborate with Manufacturing, Engineering and Supply Chain to strengthen the QMS, reduce defects, and enhance FPY, while mentoring engineers and

Qualifications

• 5–8 years of experience in Quality Engineering.
• Experience working within a regulated or certified Quality Management System.
• Experience in healthcare, medical devices or another regulated manufacturing industry is highly desirable.
• 3–5 years of experience in supplier quality management.
• 3–5 years of experience applying Lean methodologies and continuous improvement tools.
• At least 3 years of experience supervising or leading employees.
• Experience with root cause analysis, non-conformance management, CAPA and process improvement methodologies.
• Familiarity with ISO 9001, ISO 13485, MDSAP, FDA quality system requirements, EU MDR and applicable GMP/QSR requirements.
• ASQ certification or relevant quality and regulatory training is an advantage.

Responsibilities

• Quality Leadership: Lead, develop and manage the Quality team, establishing clear objectives, work assignments and performance expectations aligned with site and business quality goals.
• Manufacturing Quality: Drive improvements in incoming inspection, production quality, process controls, final inspection and product testing.
• Continuous Improvement: Lead initiatives to reduce defects, non-conformances and Defects Per Unit (DPU), while improving First Pass Yield (FPY) and overall manufacturing performance.
• Problem Solving: Lead non-conformance investigations, root cause analysis and corrective and preventive actions (CAPA) to prevent recurrence and improve product and process quality.
• Data Analysis and Reporting: Monitor, analyse and report internal and customer-facing quality metrics, identifying trends, risks and opportunities for improvement.
• Process Control: Ensure robust production and process controls are implemented and maintained in alignment with manufacturing requirements and Lean strategies.
• Supplier Quality: Collaborate with Supply Chain and suppliers to address component quality issues and support supplier quality improvement initiatives.
• Quality Management Systems: Support the implementation, maintenance and continuous improvement of the site QMS in accordance with applicable standards and regulations, including ISO 9001, ISO 13485, MDSAP, FDA requirements and EU MDR.
• Regulatory Compliance: Promote adherence to applicable quality, safety and regulatory requirements within a regulated manufacturing environment.
• People Development: Support recruitment, coaching, training and talent development to build a capable, engaged and high-performing Quality team.
• Cross-Functional Collaboration: Partner with Manufacturing, Engineering and Continuous Improvement teams to deliver sustainable improvements in product quality, operational efficiency and customer satisfaction.

Skills

Quality Leadership

Manufacturing Quality

Continuous Improvement

Problem Solving

Data Analysis

Process Control

Supplier Quality

Regulatory Compliance

People Development

Cross-Functional Collaboration

QMS & Standards

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Electromechanical Engineering

Bachelor’s degree in Biomedical Engineering

Job description

Gazelle Global is seeking a Quality Engineering Supervisor to lead the Quality team across manufacturing operations, ensuring product quality and regulatory compliance. You will oversee incoming inspection, non-conformance investigations, in-process quality control and final testing, driving data-driven improvements and CAPA programs.

You will collaborate with Manufacturing, Engineering and Supply Chain to strengthen the QMS, reduce defects, and enhance FPY, while mentoring engineers and