Quality Control Manager for Medical Devices in Milpitas!
Roth Staffing Companies

Ultimate Staffing is seeking a Quality Manager for our client in Milpitas. This is a 100% onsite, Direct Hire role, Monday-Friday 8am-5pm with a starting salary of $90K-$125K based on experience. Candidates MUST have experience in the Medical Device Industry.

Position Summary:

The Quality Manager reports directly to the Director of Quality or his/her designee and is responsible for all aspects of the Quality and Environmental Management Controls including the development, implementation, maintenance, and management of the quality policies, procedures, processes, programs, targets, and practices that are compliant to the established standards, customer specifications and production goals. The Quality Manager covers the company for all quality issues relevant to the workmanship/warrantees to represents company with customers, third party suppliers, and external auditors. The Quality Manager may perform a variety of additional tasks in accordance with their training, experience, and skill assigned by their Manager includes but not limited to:

Essential Functions and Responsibilities:

* Represent and host company in a variety of external audits (customer, notified body, FDA, fire department etc.), as and when needed, and address/close all findings/nonconformities successfully.

* Collaborate with the Corporate Quality Group for corporate audits, corporate guidance, corporate compliance, escalations, procedures, data reporting, directives, and quality tools, etc.

* Interface customers to represent company for the internal as well as the external quality failures and their closures.

* Directly responsible for the creation and maintenance of the Quality Management System that is in full compliance to the existing (and when needed, future) ISO and regulatory standards such as ISO 9001, ISO 13485, ISO 14001, and/or FDA etc.

* Manage and maintain the Environmental Health and Safety program. Closely work with Corporate managers to fulfill environment, health, and safety requirements.

* Hire, mentor, and manage the team of Quality Engineers, Quality Supervisors, Quality Inspectors, and/or other staff to meet or exceed all quality control requirements.

* Create strong quality control environment; identify, report, drive and maintain quality control goals and ongoing quality control objectives to analytically identify, report, and resolve quality issues. Responsible for managing and maintaining the Quality Control program in the plant with zero defect mindset.

* Develop and analyze statistical data and process specifications to determine yields and to establish quality of in-process and finished products. Provide technical and statistical expertise and coordinate with Operations and Manufacturing departments to maximize product quality and minimize costs.

* Prepare and present Management Reviews as mandated by the company QMS.

* Possess full understanding of the 8D process and drive effective CAPA program, help internal/external teams to perform true root cause analysis and corrective actions to eradicate the issues permanently.

* Responsible for managing the MRB and RMA programs to keep them below the established targets at all time with zero-waste mindset.

* Oversee Calibration Programs, ESD Control , NCMR Control, regular Internal Audits, and all other areas and programs relevant to a robust quality management and control system.

* Drive sustainability projects under the guidance from the Corporate directives and cover the plant in corporate as well as customer audits.

* Drive to maintain continuous improvement for the organization that include Kaizen projects, Gemba walks, and 5S disciplines.

* May be responsible for owning and maintaining the Document Control that include the full management and control of the customer, quality, and production documents.

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