Quality Assurance and Regulatory Affairs Manager

hace 4 días

Tijuana, México Emprego MX A tiempo completo

Descripción y detalle de las actividades

The Quality Assurance and Regulatory Affairs Manager will drive the strategic and operational performance of the QA department, ensures the successful delivery of business strategy and operational goals to exceed customer expectations for product quality, customer service, engineering quality, cost and delivery, while facilitating continuous improvement and achieving commercial success. The Manager will lead and manage the quality team and ensure the efficient and effective day to day running of the department. The Quality Manager must be a change agent and possess hands-on management skills. Job Functions include but are not limited to: - Assist in developing and/or executing strategic plans to meet departmental and organizational goals while complying with regulatory and customer requirements. - Lead, develop and coordinate the requirements necessary to meet ISO, FDA-GMP and customer audit compliance in the most cost-effective manner. - Manage the routine activities of the Quality Laboratory including: a) selection, development, evaluation, motivation and retention of qualified personnel; b) operation of the department within appropriate budgetary constraints; c) consistent administration of Company policies and procedures; d) maintenance of an orderly work environment. - Administration and coordination of the Customer Complaint System including assuring timely communication with the customer, sales, manufacturing, engineering and other personnel. - Continually partner with Product Development Engineers and customers to develop specifications to ensure that customer requirements and company specifications match. Resolve contradictions with customer’s specifications and procedures. - Provide leadership and guidance to assure corrective actions are resolved, adequate root cause analysis is completed and short/or long-term corrective actions are implemented. - Ensure strong communication with complaint responses or other Q.A. concerns with other departments; facilitate exchange of information in order to implement change

Experiência y requisitos

Experience: - 10 to 15 years experience related to Quality/Regulatory System Development and Management. - 5+ years of experience working in an FDA regulated environment. - 5 to 10 years experience managing people Other skills and abilities: - Understanding of FDA’s Quality System Requirements, 21CSR820, ISO 9001 and ISO 13485. - Knowledge of other regulatory processes: 510K, DMS, DMR, DHR, process validation and statistical quality tools. - Understanding and knowledge of working in a clean room manufacturing environment. - Excellent oral and written communication skills. - Excellent leadership skills. - Knowledge of lean manufacturing, Six Sigma and team problem solving.

Organización

Ivemsa

Giro

Manufacturera

Actividad principal

Administración de maquiladoras.

Número de empleados

5000

**Área** Calidad

**Contrato** Permanente

**Turno** Diurno

**Jornada** Tiempo Completo

**Horario** L-V 7:00 AM-5:00 PM

**Estudios** Titulo Profesional

**Inglés **Hablado: 95%, Escrito: 95%

**Sexo** Indistinto

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