Mam de la Frontera, S.A. de C.V.

Quality Complaint Specialist

Mam de la Frontera, S.A. de C.V.

Abr. 07

Tijuana, Baja California

Giro

Maquiladora (Export.)

Actividad principal

Maquila, shelter

Número de empleados

8000

Sitio Web corporativo

Dirección

Águila Coronada 19491

Colonia o fraccionamiento

Baja Maq El Águila

Ciudad

Tijuana, Baja California

Descripción y detalle de las actividades

Essential Job Functions • Contribute to continuous improvements to Complaint Handling process • Provides timely Adverse Event reporting. • Facilitate the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint • Collaborate with Customer Support, Engineering, and Service teams to support complaint activities • Perform reportability determinations in conjunction with medical advisor as necessary. • Be part of the Complaint Handling Unit and cross functional team of individuals through completion of investigation and closure of reportable and non-reportable product complaints in accordance with established company procedures and worldwide regulations and standards. • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • The role requires awareness of new or revised regulations and/or guidelines. • Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance • Excellent interpersonal skills • A self-starter, motivated and able to positively motivate others • Focused, target driven with a positive, can-do attitude

Experiencia y requisitos

• Bachelor’s Degree in engineering or technical field or equivalent. • Thorough knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards. • Minimum of 5-7 years’ experience working in a regulated industry or similar manufacturing and engineering environments preferred.Job Description • Highly organized and detail oriented with strong follow-up skills to manage large volumes of documentation. Ability to understand priorities. • Ability to work independently and address obstacles that may arise. • Ability to work in fast paced and dynamic environment. • Strong analytical skills. • Excellent written and verbal communication skills. • Fluent in English (both written and verbal) • Accuracy is required in performing all functions of this position. • Must demonstrate proficiency in computer skills and Microsoft Word, Excel and Visio, and Adobe Acrobat. • Lead Auditor certification a plus

Número de vacantes

1

Área

Calidad

Contrato

Permanente

Turno

Diurno

Jornada

Tiempo Completo

Estudios

Carrera Profesional

Inglés

Hablado: 90%, Escrito: 90%

Sexo

Indistinto