| Job Category : | Management |
| Company Name: | SCRUFF |
| Position Name: | Quality management system with Medical device |
| Location : | Carlsbad, CA |
| Job Description : | Company Description We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies. Job Description Responsibilities: Support, Review and Approve Validation Plans, User Requirement Specifications, Protocols and Reports and Traceability Matrices related to Validation/Qualification of Facility, Utility, Equipment and Non-Product Software.Maintain Environmental Monitoring, Material Control, Contamination Control, and other quality system procedures.Perform impact assessment, investigations on non-conformance/quality incident events, determine and implement corrections, corrective actions and actions to prevent recurrence of non-conformance events.Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Trend Quality Metrics periodically and report to Management ReviewsPerform quality system inspections in order to determine compliance to FDA, ISO, and internal quality systems requirements.Participate in continuous improvement initiatives to assure continuation of quality measurement, planning, and improvement. Perform qualifications assigned.Participate in the development, delivery, and administration of quality training programs including but not limited to GLP.Participate in internal and regulatory agencies auditsPerform any other assigned responsibility. Basic Education Qualifications: Minimum BA/BS in science, engineering or health-related discipline.Minimum 3 years of experience working in Quality Department in a medical device environment.Must have knowledge/experience in statistics, validation activities, Installation Qualification, Operation Qualification, Performance Qualification and Product Performance Qualification.A thorough understanding of the ISO 13485 standard, ISO 14971 and FDA Regulations and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed. Additional Information All your information will be kept confidential according to EEO guidelines. |