Quality Control Manager for Medical Devices in Milpitas!

Ultimate Staffing • milpitas, ca, us • 3m ago

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 General Manager or his/her designee and is responsible for all aspects of the Quality and Environmental Management Systems including the development, implementation, maintenance, and management of the quality policies, procedures, processes, programs, and practices that are compliant to the established standards, customer specifications and production goals. The Quality Manager may perform a variety of tasks in accordance with their training, experience, and skill assigned by their Manager includes but not limited to:

Essential Functions and Responsibilities:

· 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.

· 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.

· Lead a variety of external audits (customer, notified body, FDA, fire department etc.), as and when needed, and address/close all findings successfully.

· Creates strong quality control environment, a key go-to figure for all quality related topics/issues. Responsible for managing and maintaining the Quality Control program in the plant with zero defect mindset. Applies quality management tools and approaches to analytically identify, report, and resolve quality issues.

· 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 to teams as and when needed.

· Identify, drive and maintain quality control goals and ongoing quality control objectives; coordinate with Operations and Manufacturing departments to maximize product quality and minimize costs.

· Interfaces with the Corporate Quality Group for escalations, procedures, reporting, quality tools, etc.Take responsibility to drive periodic quality review meetings and take ownership to improve yields at all stages of quality control and quality assurance on the Production floor. Prepare and present Management Reviews as mandated by the company QMS.

· Drive CAPA program, help internal/external teams to drive 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 control system.

· Interface customers to represent company for the internal as well as the external quality failures.

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

· 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.

· Other relevant tasks as assigned.

Qualifications Required:

· Must have at least seven (7) years experience as a Quality Manager in a PCBA and Mechanical EMS (Electronic Manufacturing Services) Environment.

· Bachelor's Degree in a related field or equivalent.

· Proficient with PC-based software including Microsoft Office Suite, including advanced knowledge of Word, PowerPoint, and Excel.

· Kaizen and lean Manufacturing techniques, 6 sigma green belt or better

· Direct management and bring up of at least one (1) ISO standards implementation (i.e. 9001, 14001, or 13485)

· Experience with developing and documenting procedures

· Use of quality engineering methods in inspection

· Strong, effective organizational skills required; detail oriented; ability to multitask

· Demonstrated effective leadership abilities required

· Strong, effective organizational skills required; detail oriented.

· Manages conflicting priorities in a fast-paced environment, as well as partners with business executives and operations leaders in order to develop appropriate solutions.

· Ability to effectively present information and respond to questions from executives, managers and employees.

· Possess a high level of integrity in handling confidential and sensitive information.

· Must be self-directed, dependable, and motivated with excellent relationship and time management skills.

· To communicate information and state problems or challenges to be resolved in a clear, concise, courteous, nondiscriminatory and professional manner and be able to provide clarification, as necessary.

· Available to work the days and hours necessary to perform all assigned responsibilities and tasks. Must be available (especially during regular business hours or shifts) to communicate with other employees, supervisors, customers, vendors, and any other person or organization with whom interaction is required to accomplish work and goals. This may include odd hour teleconferences with global facilities.

· Quality training, document control training, quality standards, ISO, six sigma are all preferred trainings.

Mathematical Skills:

· Ability to apply basic concepts of arithmetic

Reasoning Ability:

· Ability to use common sense to solve practical problems

· Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

Physical Demands and Work Environment:

The physical demand described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.