Q105 | Quality Assurance Analyst

Q105 | Quality Assurance Analyst

02 may
Buenos Aires

02 may


Buenos Aires


- 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- Ensure superseded documents are removed from use.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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