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.
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Ensure superseded documents are removed from use.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