Quality Assurance Engineer

Detalles de la oferta

.North American Medical Corporation (NAM) is a world-class manufacturer of medical devices, specifically spinal orthopedic devices.With a mindset driven toward innovation, NAM is committed to excellence. Since 2000, North American Medical has been dedicated to advancing new therapies that work by re-establishing our body's own natural healing abilities.As the science of regenerative medicine has proven, technological innovation led with vision creates vast potential for realizing the biological power that exists in our own cellular tissues.Our mission commenced with the development of advanced technology that allows dynamic energy to be applied at specific levels and with variable waveforms, reducing pressure on spinal discs, promoting fluid exchange between vertebrae, and stimulating tissue healing, even in dried out degenerative discs.Critical to our mission has been the development of innovative clinical protocols for IDD Therapy treatment, originated in conjunction with C. Norman Shealy MD., PhD. The patented technologies that comprise the IDD Therapy treatment device, the Accu-Spina, were invented and patented by Carlos Becerra, CEO of North American Medical.With clinical studies detailing success rates over 91%, our flagship product has been recognized by the International Museum of Surgical Science for its contribution to alleviating suffering in the human condition. North American Medical treatment systems have undergone rigorous third-party laboratory safety and performance testing and have been awarded UL, CE, and ISO 13485 certifications.Only NAM manufactures systems that qualify to administer IDD Therapy (Intervertebral Differential Dynamics Therapy), one of the fastest-growing back pain intervention techniques in the US.The RoleYou will be responsible for:Ensuring compliance with Good Manufacturing Practices (GMP).Improving the quality of outputs through continuous improvement of operations (TCM).Enhancing customer satisfaction by providing accurate and value-added responses to customer concerns and issues in a timely manner.Ensuring strong process quality by driving adherence to acceptable processes.Ensuring compliance with ISO 13485 & 9001.Managing a team of 6-10 people.Competency to read, verify, and/or modify engineering drawings as needed.Design review documentation.A thorough knowledge of the PDP process.Complaint handling.Expert understanding and follow-through of the CAPA process.FMEA requirements and documentation.OSHA certification.Conducting internal audits.Leading FDA audits.Serving as management representative.Identifying the root causes of faults or problems by conducting Root Cause Analysis.Inspection and testing of various parts manufacturing, products, and components, comparing with predefined standards.Improving written procedures as needed.Enhancing operational controls for each process


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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