- 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- Ensure superseded documents are removed from use.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.
- Bachelor Degree in Life Sciences.
- 5-8 years of experience in the medical device or pharmaceutical industry.
- Fluent in English and Spanish.
Preferred Job Qualifications:
- Data analysis skills and proficiency in electronic data management systems.
- 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.