Q105 | Quality Assurance Analyst

Q105 | Quality Assurance Analyst

02 may
|
PerkinElmer
|
Buenos Aires

02 may

PerkinElmer

Buenos Aires

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- Ensure superseded documents are removed from use.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



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

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https://www.kitempleo.com.ar/empleo/6157625/q105-quality-assurance-analyst-buenos-aires/?utm_source=html

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