Quality Assurance Analyst
Buenos Aires
hace 21 horas

Buenos Aires, Mexico City, Santiago, São Paulo

PerkinElmer Inc., is looking to hire a Quality Assurance Analyst to join it's Quality Regulatory and Medical team. As a Quality Assurance Analyst, you will be responsible for supporting PerkinElmer Inc.

s Latin America entities promoting quality system compliance consistent with PerkinElmer Inc. initiatives. In this multi-discipline role, you will be a valued team member of Global Quality Systems developing expertise in multiple PerkinElmer Inc.

complaint handling, change control and training systems, and document change control processes to support PerkinElmer Inc.

Latin America entities.

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Ensure superseded documents are removed from use.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 or equivalent work experience .

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

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

Fluent in English, Spanish, Portuguese

Preferred Job Qualifications :

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

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