Quality Assurance Specialist
Cellular Technology Limited — CTL · Cleveland, OH · Yesterday
Quality AssuranceFull-time
Position Qualifications
- Bachelor’s degree in science related or engineering related scientific discipline
- Minimum of 3 years’ quality assurance experience, preferably with technical knowledge and/or experience with GLP/GCP/GMP regulations as well as experience in the Life Sciences product manufacturing industry
- Minimum 3 years of experience with Quality Management Systems (ISO 9001, ISO 13485, FDA and/or EU IVD regulations)
- Experience with CE/UL/RoHS & REACH is a plus
- Strong analytical, problem-solving, and communication skills; ability to work in a fast-paced, regulated environment
Position Description
- Create, update and maintain processes and procedures in collaboration with functional owners to ensure compliance with standards
- Perform Inspections of CRO Regulated Studies
- Lead Nonconformance, Complaint, Deviation, Change Management, Risk Management and Corrective Action Preventive Action (CAPA) processes
- Champion efforts to comply with all safety, quality and operational documentation requirements and practices
- Lead in the auditing process to ensure compliance with ISO 9001 as well as other regulations and standards
- Lead Supplier Qualification processes
- Manage Quality Surveys and Questionnaires
- Perform final quality inspections for release of products
- Maintain monitoring of inspection, calibration and maintenance processes