Vantedge Medical
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 innovation, producing vital components for medical markets such as robotic‑assisted surgery, orthopedics, surgical instruments, dental, and more. Our teams work together to meet the manufacturing needs of top Medical Original Equipment Manufacturers (OEMs) worldwide, driving quality and impacting patient care.
About the Role The Director of Quality will lead the quality organization across Vantedge Medical’s California manufacturing locations. Reporting to the Vice President of Quality and Regulatory, this role will define quality policies, oversee implementation, and drive continuous improvement of our quality systems to support production and new product introduction.
Responsibilities
Set QA policies and ensure departments meet customer requirements.
Lead resolution of significant quality issues, presenting plans and progress to senior leadership and the VP of Quality.
Participate in customer meetings and support Customer Focus Business Units.
Maintain cost of poor quality (COPQ) and total cost of quality (TCOQ) metrics, and control the QA budget.
Lead the Quality Department, achieving goals, managing expenses, staffing, and planning.
Monitor customer feedback, corrective actions, and improve quality systems.
Evaluate supplier quality via audits, surveys, and data analysis; maintain the supplier quality index.
Oversee the Material Review Board (MRB) process and establish performance metrics.
Foster a proactive culture through goal setting, team building, empowerment, succession planning, and communication.
Identify and resolve bottlenecks in inspection processes, analyzing capacity constraints.
Provide executive overviews of product schedules and timelines.
Develop Product Quality Plans as needed.
Produce periodic management reports of key QMS indicators and lead management reviews.
Collaborate with site managers to develop and improve internal auditing for audit readiness.
Ensure product conformance to customer expectations.
Promote awareness of regulatory and customer requirements throughout the organization.
Requirements
Bachelor’s degree.
8+ years of progressive management experience.
Strong hands‑on knowledge of QMS fundamentals.
Excellent communication, interpersonal, and team‑building skills.
Ability to influence senior management and collaborate with regulatory bodies.
Independent, detail‑oriented, creative, tenacious, flexible, and a team player.
Demonstrated expertise in PFMEA, process qualification, and validation.
Strong knowledge of ISO 13485; knowledge of ISO 9001 and/or 21 CFR Part 820 is desired.
Minimal travel required.
Benefits
Medical – Dental – Vision – Life Insurance
Vacation and Sick Pay
401(k) matching
Location & Compensation San Jose, CA – Onsite (relocation supported). Salary: $209k – $230k plus bonus and benefits.
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About the Role The Director of Quality will lead the quality organization across Vantedge Medical’s California manufacturing locations. Reporting to the Vice President of Quality and Regulatory, this role will define quality policies, oversee implementation, and drive continuous improvement of our quality systems to support production and new product introduction.
Responsibilities
Set QA policies and ensure departments meet customer requirements.
Lead resolution of significant quality issues, presenting plans and progress to senior leadership and the VP of Quality.
Participate in customer meetings and support Customer Focus Business Units.
Maintain cost of poor quality (COPQ) and total cost of quality (TCOQ) metrics, and control the QA budget.
Lead the Quality Department, achieving goals, managing expenses, staffing, and planning.
Monitor customer feedback, corrective actions, and improve quality systems.
Evaluate supplier quality via audits, surveys, and data analysis; maintain the supplier quality index.
Oversee the Material Review Board (MRB) process and establish performance metrics.
Foster a proactive culture through goal setting, team building, empowerment, succession planning, and communication.
Identify and resolve bottlenecks in inspection processes, analyzing capacity constraints.
Provide executive overviews of product schedules and timelines.
Develop Product Quality Plans as needed.
Produce periodic management reports of key QMS indicators and lead management reviews.
Collaborate with site managers to develop and improve internal auditing for audit readiness.
Ensure product conformance to customer expectations.
Promote awareness of regulatory and customer requirements throughout the organization.
Requirements
Bachelor’s degree.
8+ years of progressive management experience.
Strong hands‑on knowledge of QMS fundamentals.
Excellent communication, interpersonal, and team‑building skills.
Ability to influence senior management and collaborate with regulatory bodies.
Independent, detail‑oriented, creative, tenacious, flexible, and a team player.
Demonstrated expertise in PFMEA, process qualification, and validation.
Strong knowledge of ISO 13485; knowledge of ISO 9001 and/or 21 CFR Part 820 is desired.
Minimal travel required.
Benefits
Medical – Dental – Vision – Life Insurance
Vacation and Sick Pay
401(k) matching
Location & Compensation San Jose, CA – Onsite (relocation supported). Salary: $209k – $230k plus bonus and benefits.
#J-18808-Ljbffr