Número de empleados
Sitio Web corporativo
Descripción y detalle de las actividades
- Understand and ensure compliance to the Iso:135485, CFR, MDD and clients Quality system requirements. - Communicate with management regarding any issue that affects product quality or complaint. - Customer quality interface for assigned customers and suppliers; manage the customer complaint process. - Provide quality support to new product/process development. -Manage the supplier quality management program for the assigned customers. - Investigation and correction of internal, customer, and supplier quality issues. -Manage MRB/NCMR process for assigned customers. -Lead product, process, and component root cause failure analysis with appropriate corrective action, preventive action, and containment. action. -Evaluation and approval of proposed changes to the client quality management system, validations, and deviations. - Consultant to Value Stream and other departments for the quality management system and regulatory requirements. -Member of cross-functional teams for company projects. - Execute assigned tasks independently.
Experiencia y requisitos
- Bachelor's degree in Engineering, Biology, or another applicable field of study. - 3+ years in a regulated manufacturing environment. - Demonstrated track record of problem-solving ability in a cross-functional environment. - Excellent communication skills, with the ability to interface with every level of the client and or customers. - Data-driven, keen analytical ability; skilled and effective problem solver. - Self-motivated and able to operate independently or as an effective team member. - Pragmatic approach, assuring quality while never letting perfect getting in the way of excellent. - Microsoft office suite, Eto/Gamma sterilization, statistics, quality management tools, problem-solving, root cause analysis, project management, supplier management, APQP, ISO 13485, CFR, MDR. -Ability to work from home on occasion, with advance approval.
Número de vacantes