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.
Top Skills
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing.
We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
