Vantedge Medical
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$170,000.00/yr - $190,000.00/yr Director of Quality Full-time / Permanent $170K - $190k Overview
About Us:
Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We specialize in precision engineering and the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. We collaborate across teams to meet the manufacturing needs of top Medical Original Equipment Manufacturers (OEMs) worldwide. We are committed to advancing medical technology and take pride in our work. About this Opportunity
The Director of Quality will lead the quality organization by overseeing all Quality Assurance efforts at our San Jose, California location. Working with the Vice President of Quality and Regulatory, this role supports the site quality goals and metrics. The Director develops and executes the company\'s process control systems, drives implementation, and sustains quality systems in support of production and development programs (New Product Introduction). The Director will be a positive change agent for the site. Responsibilities
Set QA policies for the San Jose site and ensure departments meet customer requirements. Take lead on significant quality issues; be hands-on, develop resolution plans, and communicate progress to site Senior Leadership, the VP of Quality and Regulatory, and the organization. Partner with Operations to maintain a culture of high quality and customer satisfaction; mentor and drive positive change. Support Customer Focus Business Units (CFBU) as required and participate in customer meetings. Maintain and review COPQ and TCOQ, including internal and external failure costs; manage the QA budget. Lead and manage the Quality Department to achieve goals, manage budgets, staffing, and planning. Monitor customer feedback and corrective actions; improve quality systems accordingly. Assess supplier quality through site visits, audits, surveys, and data analysis; oversee the supplier quality index and remediation as needed. Oversee the Material Review Board (MRB) process and track key metrics to meet site goals. Foster a proactive culture through goal setting, team building, empowerment, succession planning, and clear communication. Identify bottlenecks in incoming, in-process, metrology lab, and outgoing inspection processes; evaluate headcount, equipment, and capacity constraints. Provide executive overviews of product schedules and timelines using project management techniques. Develop Product Quality Plans as appropriate. Chair and lead Management Review Meetings as required by the QMS. Collaborate with site managers to develop and continuously improve internal auditing; strive for 24/7 audit readiness. Ensure product conformance to customer expectations and promote awareness of regulatory and customer requirements throughout the organization. Requirements / Skills
Bachelor’s degree in business, engineering or a scientific field. 8 years of progressively responsible management experience. Strong knowledge of ISO13485 is required. Knowledge of ISO9001 and/or FDA 820 is desired. Strong hands-on knowledge of the fundamentals of QMS. Strong communication and interpersonal skills. Strong team-building skills within a rapidly growing environment. Ability to collaborate with a strong management team and positively influence groups as needed. Ability to professionally represent the company with external organizations and regulatory bodies. Demonstrated PFMEA, Process Qualification and Validation expertise. Job function
Quality Assurance Industries
Appliances, Electrical, and Electronics Manufacturing and Manufacturing Fremont, CA, and other locations may be listed for market comparison in job postings.
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$170,000.00/yr - $190,000.00/yr Director of Quality Full-time / Permanent $170K - $190k Overview
About Us:
Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full-scale manufacturing. We specialize in precision engineering and the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. We collaborate across teams to meet the manufacturing needs of top Medical Original Equipment Manufacturers (OEMs) worldwide. We are committed to advancing medical technology and take pride in our work. About this Opportunity
The Director of Quality will lead the quality organization by overseeing all Quality Assurance efforts at our San Jose, California location. Working with the Vice President of Quality and Regulatory, this role supports the site quality goals and metrics. The Director develops and executes the company\'s process control systems, drives implementation, and sustains quality systems in support of production and development programs (New Product Introduction). The Director will be a positive change agent for the site. Responsibilities
Set QA policies for the San Jose site and ensure departments meet customer requirements. Take lead on significant quality issues; be hands-on, develop resolution plans, and communicate progress to site Senior Leadership, the VP of Quality and Regulatory, and the organization. Partner with Operations to maintain a culture of high quality and customer satisfaction; mentor and drive positive change. Support Customer Focus Business Units (CFBU) as required and participate in customer meetings. Maintain and review COPQ and TCOQ, including internal and external failure costs; manage the QA budget. Lead and manage the Quality Department to achieve goals, manage budgets, staffing, and planning. Monitor customer feedback and corrective actions; improve quality systems accordingly. Assess supplier quality through site visits, audits, surveys, and data analysis; oversee the supplier quality index and remediation as needed. Oversee the Material Review Board (MRB) process and track key metrics to meet site goals. Foster a proactive culture through goal setting, team building, empowerment, succession planning, and clear communication. Identify bottlenecks in incoming, in-process, metrology lab, and outgoing inspection processes; evaluate headcount, equipment, and capacity constraints. Provide executive overviews of product schedules and timelines using project management techniques. Develop Product Quality Plans as appropriate. Chair and lead Management Review Meetings as required by the QMS. Collaborate with site managers to develop and continuously improve internal auditing; strive for 24/7 audit readiness. Ensure product conformance to customer expectations and promote awareness of regulatory and customer requirements throughout the organization. Requirements / Skills
Bachelor’s degree in business, engineering or a scientific field. 8 years of progressively responsible management experience. Strong knowledge of ISO13485 is required. Knowledge of ISO9001 and/or FDA 820 is desired. Strong hands-on knowledge of the fundamentals of QMS. Strong communication and interpersonal skills. Strong team-building skills within a rapidly growing environment. Ability to collaborate with a strong management team and positively influence groups as needed. Ability to professionally represent the company with external organizations and regulatory bodies. Demonstrated PFMEA, Process Qualification and Validation expertise. Job function
Quality Assurance Industries
Appliances, Electrical, and Electronics Manufacturing and Manufacturing Fremont, CA, and other locations may be listed for market comparison in job postings.
#J-18808-Ljbffr