Quality Control Manager for Medical Devices in ...

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 hisher 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 workmanshipwarrantees 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 addressclose all findingsnonconformities 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, andor 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, andor 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 internalexternal 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.* 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. * Knowledge of 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.While performing the duties of the job, the employee is regularly required to sit, stand andor walk for extended periods of time; use hands and fingers to handle panels and boards; reach with hands and arms; and talk and hear. The employee must occasionally lift andor move up to 30 pounds and have steady hands and dexterity. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Decision Making Authority:* Ability to use common sense to solve practical problems* Ability to conduct reviews of documents* Ability to interpret a variety of instructions furnished in written and oral form* Identify problems, understand them, and develop effective solutions. Financial Responsibility:* Errors in execution of Document control responsibilities* Ongoing communication with internal customers, auditors, employees, management. EMAIL RESUME All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Created: 2024-11-06