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Quality Assurance Analyst- Bilingual Spanish & English

São Paulo, Brazil | Buenos Aires, Argentina | Mexico City, Mexico | Santiago, Chile

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Responsibilities

Location São Paulo, São PauloBR Job ID JR-016588

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.

Please send your resume in English- Thank you

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  • Ensure superseded documents are removed from use.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.

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

  • Fluent in English and Spanish.

Preferred Job Qualifications:

  • 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.

Apply Now

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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