Job expirat
Role: Manages regulatory compliance for all medical projects.
MAIN RESPONSIBILITIES
- Performs Advanced Quality Planning for medical projects
-Prepares Quality Plan for Medical products based on Solectron processes, market segment, regulatory and customer specific requirements;
- Coordinates Risk Assessments/FMEAs;
- Issues Validation Master Plan;
- Coordinates Equipment Installation Qualification, Operational Qualification, Process Qualification;
- Ensures compliance with ISO 13485 and FDA requirements;
- Verifies responses to customer complaints (ensures true root cause analysis was performed, robust containment and corrective actions were implemented);
- Keeps validation records;
- Solectron interface to 3rd party assessment agencies for medical certifications;
- Participates in internal auditing responsibilities (e.g. system audits, process/product audits);
PERSON ¿ higher weighting more important
¿ Bachelors in Technical field
¿ Minimum 3 years experience in a quality / engineering function
- Ability to effectively execute project plans
- Knowledge of medical standards and regulatory requirements (ISO 13485, FDA)
- English language: good command (written and spoken)
- Good skills to problem solving and improvement
- MS Office knowledge|
- Good communication skills
- Proven analytical skills, dynamic, well organized, self-motivated and open to learn
- Previous experience with medical products and FMEA will be a plus
- Ability to communicate technically with customers and 3rd Party assessment agencies
- Team working skills
Solectron is a leading global provider of electronics manufacturing and integrated supply chain services. We serve the world\'s most innovative companies in industries that rely on high-tech electronics. Our 2,500 employees in Romania have a hand in designing, making and servicing products that people around the world rely on every day.