Director of Quality

Job Type

Director of Quality  - Full-time / Permanent

San Jose, CA - onsite

Salaried | $209k - $230K with Bonus and Benefits

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 the Role: Â The Director of Quality will effectively lead the quality organization by overseeing all Quality Assurance efforts within the Vantedge Medical California Manufacturing locations. Working in conjunction with the Vice President of Quality and Regulatory, this role will support the quality goals and quality metrics for the California sites. The Director of Quality develops and executes the company's process control systems. They drive and monitor the implementation process of these systems and the successful implementation and sustainment of the quality systems in support of various production and development programs (New Product Introduction). The Director of Quality reports to the Vice President of Quality and Regulatory for Vantedge Medical.

Responsibilities:

• This role is responsible for setting the QA policies and ensuring the departments meet customer requirements.
• Take the lead responsibility for significant quality issues. Be “hands on” with the issue, develop a plan to resolve the issue, communicate the plan and progress on the plan to the site Senior Leadership team, organization, and Vice President of Quality and Regulatory.
• Participate and support the Customer Focus Business Units (CFBU) as required and take an active role in customer meetings.
• Maintain and review cost of poor quality (COPQ) and total cost of quality (TCOQ) including internal and external failure costs. Maintain budgetary control over the Quality Assurance function.
• Lead and manage the Quality Department ensuring achievement of department and Company’s goals, objectives, adherence to expense budgets, and effective staffing and planning.
• Monitor customer feedback and corrective actions and make improvements to improve the quality systems based on this feedback.
• Analyze and evaluate quality and reliability capabilities of potential and existing suppliers, as applicable through site visits, audits, surveys and/or data analysis. Develop and maintain oversight of the supplier quality index to ensure only high-quality suppliers are retained and or put on a corrective action plan, as applicable.
• Have overall responsibility of the Material Review Board (MRB) process. Establish key metrics to analyze and monitor performance to achieve site level goals.
• Provide the leadership necessary to establish a proactive culture through effective use of goal setting, team building, employee empowerment, succession planning and communication.
• Identify and solve bottlenecks in the incoming, in-process, CMM, metrology, and outgoing inspection processes. This analysis will pertain to headcount, equipment, operating hours and/or other capacity constraints.
• Provide an executive overview of all product schedules and network timelines through effective communication and project management techniques.
• Develop Product Quality Plans as appropriate.
• Provide periodic management reports of key QMS indicators. Lead periodic Management Reviews.
• Working and collaborating with the site managers, lead the development and continual improvement of the internal auditing program with a goal for continuous internal and external audit readiness.
• Primary responsibility for product conformance to customer expectations.
• Ensure the promotion of awareness of regulatory and customer requirements throughout the organization.

Requirements

• Bachelor’s degree.
• 8 years of progressively responsible management experience.
• Must have strong hands-on knowledge of the fundamentals of QMS.
• Strong communication and interpersonal skills are essential, most importantly strong team building skills within a rapidly growing environment.
• Must be comfortable working with a strong management team and able to positively influence the group when necessary.
• Ability to professionally represent the company when collaborating with external organizations and regulatory bodies.
• Independent, detail-oriented, creative, tenacious, flexibility and a team player are essential characteristics.
• Demonstrated PFMEA, Process Qualification and Validation expertise.
• Strong knowledge of ISO13485 is required.
• Knowledge of ISO9001 and/or 21CFR Part 820 is desired.
• Travel: Minimal

Benefits:

• Medical – Dental – Vision – Life Insurance
• Vacation and Sick Pay
• 401k