Vantedge Medical · 1 day ago
Director of Quality
San Jose, CA
Full-time
Onsite
Director/Executive
$209K/yr - $230K/yr
8+ years expVantedge Medical is the premier metals-based med-tech solutions partner specializing in the development and manufacturing of vital components for medical markets. The Director of Quality will lead the quality organization, overseeing all Quality Assurance efforts and ensuring compliance with quality goals and metrics across California manufacturing sites.
ManufacturingMedicalMedical Device
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
Qualification
Required
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
Travel: Minimal
Preferred
Knowledge of ISO9001 and/or 21CFR Part 820 is desired
Company
Vantedge Medical
Vantedge Medical offers medical equipment manufacturing services.
1001-5000 employees