Vantedge Medical
Director of Quality
Location - San Jose, CA
Employment type: Full-time / Permanent
Base pay range $209,000.00/yr - $230,000.00/yr
Relocation supported. Elevate your career in sunny San Jose, California, with a fantastic new role —
Relocation assistance
is available for the ideal US-based candidate.
About Us: Vantedge Medical is the premier metals-based med‑tech solutions partner from concept to full‑scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as robotic assisted surgery, orthopedics, surgical instruments, dental, and more. Our teams work in unison, collaborating and problem‑solving to serve the manufacturing needs of the top medical original equipment manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do – and have a lot of fun doing it.
About this Opportunity: The Director of Quality will effectively lead the quality organization by overseeing all quality assurance efforts within our San Jose, California location. Working in conjunction with the Vice President of Quality and Regulatory, this role will support the quality goals and quality metrics for the site. The Director of Quality develops and executes the company's process control systems, drives and monitors implementation, and ensures sustainment of the quality systems in support of various production and development programs (new product introduction). The Director of Quality will be a positive change agent for the site.
Responsibilities:
Set the QA policies for the San Jose site and ensure departments meet customer requirements.
Take lead responsibility for significant quality issues; be hands‑on, develop a plan, communicate progress to senior leadership and Vice President.
Partner with operations to improve and maintain a culture of high quality and customer satisfaction; mentor and drive positive change.
Participate in and support the customer focus business units; take an active role in customer meetings.
Maintain and review cost of poor quality (COPQ) and total cost of quality (TCOQ); control the quality assurance budget.
Lead and manage the quality department to achieve goals, objectives, expense budgets, and effective staffing.
Monitor customer feedback and corrective actions; make improvements to adjust quality systems.
Analyze and evaluate quality and reliability of suppliers through visits, audits, surveys, or data analysis; maintain supplier quality index.
Oversee the material review board (MRB) process and monitor performance metrics.
Establish a proactive culture through goal setting, team building, empowerment, succession planning, and communication.
Identify and solve bottlenecks in inspection processes; analyze headcount, equipment, operating hours, and capacity constraints.
Provide executive oversight of product schedules and network timelines through effective communication.
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 program; strive for 24/7 audit readiness.
Ensure product conformance to customer expectations.
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 ISO 13485.
Knowledge of ISO 9001 and/or FDA 820 is desired.
Hands‑on knowledge of the fundamentals of QMS.
Strong communication and interpersonal skills.
Team building skills within a rapidly growing environment.
Comfortable collaborating with a strong management team.
Ability to positively influence a group when necessary.
Ability to professionally represent the company when dealing with external organizations and regulatory bodies.
Demonstrated PFMEA, process qualification, and validation expertise.
Seniority level Director
Employment type Full-time
Job function Quality Assurance
Industries Appliances, Electrical, and Electronics Manufacturing; Manufacturing; Medical Equipment Manufacturing
#J-18808-Ljbffr
Employment type: Full-time / Permanent
Base pay range $209,000.00/yr - $230,000.00/yr
Relocation supported. Elevate your career in sunny San Jose, California, with a fantastic new role —
Relocation assistance
is available for the ideal US-based candidate.
About Us: Vantedge Medical is the premier metals-based med‑tech solutions partner from concept to full‑scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as robotic assisted surgery, orthopedics, surgical instruments, dental, and more. Our teams work in unison, collaborating and problem‑solving to serve the manufacturing needs of the top medical original equipment manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do – and have a lot of fun doing it.
About this Opportunity: The Director of Quality will effectively lead the quality organization by overseeing all quality assurance efforts within our San Jose, California location. Working in conjunction with the Vice President of Quality and Regulatory, this role will support the quality goals and quality metrics for the site. The Director of Quality develops and executes the company's process control systems, drives and monitors implementation, and ensures sustainment of the quality systems in support of various production and development programs (new product introduction). The Director of Quality will be a positive change agent for the site.
Responsibilities:
Set the QA policies for the San Jose site and ensure departments meet customer requirements.
Take lead responsibility for significant quality issues; be hands‑on, develop a plan, communicate progress to senior leadership and Vice President.
Partner with operations to improve and maintain a culture of high quality and customer satisfaction; mentor and drive positive change.
Participate in and support the customer focus business units; take an active role in customer meetings.
Maintain and review cost of poor quality (COPQ) and total cost of quality (TCOQ); control the quality assurance budget.
Lead and manage the quality department to achieve goals, objectives, expense budgets, and effective staffing.
Monitor customer feedback and corrective actions; make improvements to adjust quality systems.
Analyze and evaluate quality and reliability of suppliers through visits, audits, surveys, or data analysis; maintain supplier quality index.
Oversee the material review board (MRB) process and monitor performance metrics.
Establish a proactive culture through goal setting, team building, empowerment, succession planning, and communication.
Identify and solve bottlenecks in inspection processes; analyze headcount, equipment, operating hours, and capacity constraints.
Provide executive oversight of product schedules and network timelines through effective communication.
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 program; strive for 24/7 audit readiness.
Ensure product conformance to customer expectations.
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 ISO 13485.
Knowledge of ISO 9001 and/or FDA 820 is desired.
Hands‑on knowledge of the fundamentals of QMS.
Strong communication and interpersonal skills.
Team building skills within a rapidly growing environment.
Comfortable collaborating with a strong management team.
Ability to positively influence a group when necessary.
Ability to professionally represent the company when dealing with external organizations and regulatory bodies.
Demonstrated PFMEA, process qualification, and validation expertise.
Seniority level Director
Employment type Full-time
Job function Quality Assurance
Industries Appliances, Electrical, and Electronics Manufacturing; Manufacturing; Medical Equipment Manufacturing
#J-18808-Ljbffr