Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
- Quality Specialist
- Will support implementation of new product model to the CRM Division. Ideal candidate should have experience with the following:
- Previous experience in quality assurance (Required)
- Previous experience with Boston Scientific (Preferred).
- Experience with change assessments, process validations, ESQ and software validations.
- Experience in risk management and line clearance, PFMEA, Risk Analysis
- Knowledge of systems such as Windchill, Ecapa, MES, BMRAM, etc
- Process Monitors Setup, control charts
- Changes (generation and review/approval) of MIs, CNs, PCAs
- MES knowledge (for Line Verification exercise)
- Education: Bachelor’s degree in engineering or science Field
- Timeframe: 3 months with potential to extend up to 6 months
- Will support implementation of new product model to the CRM Division. Ideal candidate should have experience with the following:
Candidate could be assigned as reviewer and/or approver for the quality role. Could own and lead deliverables for product commercialization readiness. Able to coordinate testing and execution. Generate and/or update documentation (e.g. change assessments per applicable procedures, change notices, procedures, certifications, Eps, line verification). Resource should be self-driven, have good communication skills, planning skills and motivated.