Senior Quality Manager

Vantedge Medical - VDB•San Jose, CA

7d•$167,000 - $190,000•Onsite

About The Position

The Senior Quality Manager will effectively lead the quality organization for the Vantedge Medical San Jose manufacturing site, working in conjunction with the Vice President of Quality to support the site's quality goals and metrics. This role holds overall accountability for Quality Systems, Quality Engineering, and Quality Control at the site, and directly leads Quality Engineering while providing oversight and direction to the Quality Control Manager and the site's Quality Control function. The Senior Quality Manager interfaces directly with customers and suppliers on quality processes and improvements, drives the site's process control systems, and supports the successful implementation and sustainment of the quality system across production and development (New Product Introduction) programs. Travel is minimal and generally limited to occasional cross-site collaborative projects.

Requirements

Applicable Bachelor Degree in Engineering (or related technical field), preferred.
8–10 years of progressively responsible experience in a quality function within a regulated manufacturing environment, including at least 5 years in Quality Engineering and/or quality leadership – people management experience.
Background in metal manufacturing (machining, forming, punching, welding, etc.) or a similar industrial sector strongly preferred.
Strong, hands-on knowledge of QMS fundamentals; demonstrated PFMEA, process qualification, and validation expertise.
Strong working knowledge of ISO 13485 and ISO 9001 required; knowledge of FDA 21 CFR Part 820 desired.
General inspection and product/process validation knowledge, including design of fixtures and inspection tools, methodology, mechanical design, and metrology.
Strong background in manufacturing, including machining, metal fabrication and joining, and process validation such as welding, plating, and painting.
Strong communication and interpersonal skills, most importantly strong team-building skills; ability to work effectively with a strong management team and positively influence the group when necessary; experience managing a direct-report manager preferred.
Independent, detail-oriented, creative, tenacious, flexible, and a collaborative team player.
Ability to professionally represent the company with customers, suppliers, and regulatory bodies as needed.
Good computer skills.

Nice To Haves

Applicable Bachelor Degree in Engineering (or related technical field)
Background in metal manufacturing (machining, forming, punching, welding, etc.) or a similar industrial sector
Knowledge of FDA 21 CFR Part 820
Experience managing a direct-report manager

Responsibilities

Directly manage Quality Engineering as a working manager, acting as the site's QE subject matter expert; use statistical techniques to detect negative trends and identify opportunities for improvement.
Provide direct oversight and leadership to the Quality Control Manager and the Quality Control function, ensuring inspection, containment, and disposition activities meet site quality and schedule requirements.
Take lead responsibility for significant quality issues: be hands-on with the issue, develop a plan to resolve it, and communicate the plan and progress to site leadership and the Vice President of Quality.
Serve as the Voice of the Customer during internal communications and take an active role in customer meetings focused on continuous product/process improvement and cost reduction.
Advise customers on manufacturing capabilities to support successful realization of their requirements.
Create and/or review operating procedures, quality procedures, and manufacturing practices as needed, partnering with the Quality Control Manager on inspection-specific procedures and work instructions.
Develop and maintain QMS documentation in coordination with the Director, Quality Assurance, to meet the goals and objectives set by the Vice President of Quality.
Hold overall accountability for the Material Review Board (MRB) process; provide direction to the Quality Control Manager and MRB Coordinator on disposition of non-conforming material, customer returns/complaints, and corrective action.
Establish and monitor key quality metrics to track and achieve site-level goals.
Maintain and review the site's cost of poor quality (COPQ), including internal and external failure costs.
Submit budget requests and help develop the Quality department's annual operating budget; final budget authority for the site rests with the Site Director, while Quality maintains an independent reporting line to the Vice President of Quality for transparency and objectivity.
Analyze and evaluate the quality and reliability of suppliers relevant to the site through audits, surveys, and/or data analysis, and maintain the site's supplier quality index, ensuring only high-quality suppliers are retained or placed on a corrective action plan.
Identify and solve bottlenecks in incoming, in-process, metrology lab (including CMM), and outgoing inspection processes, pertaining to headcount, equipment, operating hours, and other capacity constraints.
Lead the site's internal auditing program in collaboration with site management, driving continuous improvement and working toward 24/7 internal and external audit readiness.
Maintain the site's compliance with both the ISO 13485 and ISO 9001 Quality Management System standards.
Serve as the site's QMS Management Representative to registrar auditors for ISO 13485 and ISO 9001.
Monitor customer feedback and corrective actions, and adjust the site's quality systems based on that feedback.
Develop Product Quality Plans as appropriate.
Provide periodic management reports of key QMS indicators to site and quality leadership.
Provide the leadership needed to build a proactive quality culture at the site through goal setting, team building, employee empowerment, and staff development – including developing the Quality Control Manager and the broader quality team.
Ensure Vantedge's QA policies and awareness of regulatory and customer requirements are consistently applied and promoted across the site.
Work with all departments to build a shared understanding of manufacturing quality and its application.
Participate in occasional cross-site collaborative projects as needed; travel is minimal and limited to these initiatives.
Undertake additional responsibilities as needed to improve site quality and compliance.