Senior Quality Manager
hace 2 semanas
The Quality Manager will be responsible for leading a team of Engineers and overseeing day-to-day operations, including Corrective and Preventive Actions (CAPA) and Non-Conformance Reports (NCRs). This role involves providing support for New Product Development launches, addressing Risk Management issues associated with Regulated Products, and driving site Quality Metrics such as Complaints, CAPAs, NCRs, and Cost of Quality. The Quality Manager will play a pivotal role in promoting a strong Quality Culture within the organization and will serve as the Quality Management Representative, making key decisions regarding Quality. Additionally, the role will involve liaising with suppliers, customers, and regulatory bodies as needed, while adhering to ISO, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP) standards.
**Role Requirements**:
- Bachelor's degree in Engineering, Math, or Statistics. Master's degree preferred.
- ASQ (American Society for Quality) certification is preferred.
- Regulatory Affairs Professional Society (RAPS) medical device certification is preferred.
- A minimum of 10-12 years of experience in quality or technical functions within the medical device industry, with 3-5 years in a managerial role.
- Proven project management, team development, and management skills.
- Excellent written and oral communication skills, including the ability to effectively communicate with Executive-level staff, FDA, and customers. Strong technical writing skills are essential.
- Demonstrated strong leadership skills with a track record of driving positive results.
- Experience with Class III and Implantable medical devices is an advantage.
**Key Responsibilities**:
Lead a team of Engineers to oversee day-to-day quality operations, including CAPA and NCR management.
Provide support for New Product Development launches, ensuring quality standards are met.
Address Risk Management issues associated with Regulated Products, implementing effective mitigation strategies.
Drive site Quality Metrics, including Complaints, CAPAs, NCRs, and Cost of Quality, to meet and exceed established benchmarks.
Promote and support a strong Quality Culture within the organization.
Play a key role in making decisions regarding Quality, serving as the Quality Management Representative.
Liaise with suppliers, customers, and regulatory bodies as necessary to maintain compliance and quality standards.
Ensure compliance with ISO, GMP, and GDP standards, staying up-to-date with regulatory changes and requirements.
Tipo de puesto: Tiempo completo
Puede trasladarse/mudarse:
- Montevideo, Departamento de Montevideo: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)
Experiência:
- Dispositivos Medicos: 1 año (Deseable)
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