Quality Assurance Analyst- Bilingual Spanish & English

Quality Assurance Analyst- Bilingual Spanish & English

26 sep
|
PerkinElmer
|
Metropolitana

26 sep

PerkinElmer

Metropolitana

Responsibilities:



- Review complaints and determine eligibility for adverse event reporting



- Evaluate and track complaints through complaint process workflow to closure



- Coordinate complaint closures per established business metrics.



- Ensure completeness of complaint files prior to closure



- Collaborate with a variety of diverse persons such as Engineers, Scientists, Clinical Specialists, Field Service Engineers, Professional Customers and Manufacturing personnel to facilitate the complaint investigation process globally.



- Assist with internal/external audits in support of complaint handling, document control, supplier quality and training activities









- Compile complaint trends for management review and support of product reliability reviews



- Coordinate and compile department metrics to support management review meetings



- Process change orders for new and revised documents including engineering, manufacturing and quality system documents



- Coordinate the change control function for product improvements and new product development



- Ensure all document changes are processed



- Manage distribution and archiving of controlled documents and records in compliance with PerkinElmer procedures



- Ensure superseded documents are removed from use.



- Create or revise documents in support of system, product or process changes.



- Collaborate with site management to develop training curricula and ensure personnel are appropriately assigned to curricula



- Provide summary reports for training compliance to site management



- Compile department metrics and report metrics to management via reports and/or review meetings.



- Assist with the qualification of new suppliers and communicate to teams as necessary



- Request supplier documentation, maintain approved supplier lists for qualified suppliers, update supplier records and communicate to teams as necessary



- Provide data regarding quality performance analysis and reporting for suppliers



- Schedule and prepare meeting agendas for Global Change Control Board.



- Generate and distribute Change Control Board meeting minutes.



Job Qualifications:



- Bachelor Degree in Life Sciences.



- 5-8 years of experience in the medical device or pharmaceutical industry.



- Fluent in English and Spanish.



Preferred Job Qualifications:



- Data analysis skills and proficiency in electronic data management systems.



- Fluent in Portuguese.



- Ability to work in a matrixed organizational structure, developing strong relationships with multi-national business partners



- Exceptional attention to detail



- Ability to take direction and multi-task in a fast-paced environment



- Ability to work independently with minimal supervision



- Strong data analysis skills and proficiency in electronic data management systems



- Superior interpersonal, verbal and written communication skills



- Exceptional organizational, negotiation, and problem-solving skills



If you are interested in applying for this role, please submit your resume in English.

(CLA) Ejecutivo(a) Call Center 45 hrs.- $434.000.-

(CLA) Ejecutivo(a) Call Center 45 hrs.- $434.000.-

- ¡En Konecta te ofrecemos ser parte del equipo de Talento K!, creemos en el desarrollo de las personas y por lo mismo entregamos no solo oportunidades de trabajo, también oportunidades de crecimiento. Estamos en la búsqueda de EJECUTIVOS C [...]
Macul
15 oct
    Macul
    15 oct

Paramédico 7x7 Sur Oriente En Región Metropolitana - cod:292177

Paramédico 7x7 Sur Oriente En Región Metropolitana - cod:292177

- Somos una Empresa de servicios filial de la Asociación Chilena de Seguridad (ACHS), que cuenta con el respaldo y trayectoria de la mutualidad líder en Chile. La invitación es a desafiarte día a día para brindar un servicio de excelencia apo [...]
La Florida
15 oct
    La Florida
    15 oct

Vendedora

Vendedora

Empresa líder en arriendo de maquinarias para construcción, con más de 3 años de experiencia, requiere contratar a una Vendedora en Terreno, el cual pueda desempeñar el cargo con la responsabilidad de ofertar y vender nuestros productos, mantene [...]
Metropolitana
15 oct
    Metropolitana
    15 oct

Captadora de clientes

Captadora de clientes

B&S Somos corredora de propiedades y buscamos personas proactivas, responsables, con ansias de superación, excelente trato, y enfoque hacia el cliente, con experiencia en el rubro de captación para arriendo y venta de propiedades domiciliarias, gal [...]
Metropolitana
15 oct
    Metropolitana
    15 oct