Quality Engineering Supervisor

Vantedge Medical Company; San Jose (CA); Hybrid; USD 140,000 - 180,000; Full time

Job summary

Vantedge Medical seeks a Quality Engineer Supervisor to lead the San Jose Quality Engineering team. You will oversee quality planning, investigations, validation, CAPA, and continuous improvement across machining, sheet metal, and electro‑mechanical assembly.

Reporting to the Quality Director, you will partner with operations, NPI, supply chain, and customers to ensure regulatory and customer requirements are met, while driving robust quality processes and metrics.

Qualifications

• Bachelor's degree in Quality, Mechanical, Manufacturing, Industrial, or Electrical Engineering.
• 7+ years of progressive Quality Engineering or manufacturing quality experience.
• At least 3 years in technical leadership, project leadership, or people management.
• Experience in a regulated medical-device manufacturing environment is preferred.
• Strong knowledge of ISO 13485; ISO 9001 and 21 CFR Part 820 is desirable.
• Experience with PFMEA, control plans, process qualification and validation, SPC, GR&R.

Responsibilities

• Lead and coach the San Jose Quality Engineers; set priorities and monitor deliverables.
• Provide day-to-day leadership across machining, sheet metal fabrication, and electro‑mechanical assembly.
• Act as escalation point for significant quality issues; lead cross‑functional problem solving.
• Support customer meetings, quality reviews, and CAPA responses.
• Develop and review PFMEA, control plans, inspection plans, and sampling strategies.
• Lead supplier quality improvements and participate in MRB activities.
• Maintain ISO 13485 and ISO 9001 compliance and support audits.

Skills

Leadership

Quality engineering

Problem solving

Communication

Statistical analysis

Education

Bachelor's degree in Quality/Mechanical/Manufacturing/Industrial/Electrical Engineering

Tools

Minitab

JMP

QMS/ERP

CMM/vision metrology

Job description

Description

Job Details

Job Type

Full-time

San Jose, CA

Description

Quality Engineer Supervisor

Job Type Full-time

San Jose, CA

Full-time | Permanent | Onsite

Salaried | $140k - $180k

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:

The Quality Engineering Supervisor leads the Quality Engineering team supporting the San Jose site's machining, sheet metal fabrication, and electro-mechanical assembly value streams. Reporting to the Director of Quality, this hands-on leader is accountable for effective product and process quality planning, engineering investigations, validation, corrective action, and continual improvement. The role partners closely with Operations, Manufacturing Engineering, New Product Introduction, Supply Chain, Quality Control, and customers to ensure products and processes meet applicable customer, regulatory, and Quality Management System requirements.

Responsibilities:

• Lead, coach, and develop the San Jose Quality Engineers; establish priorities, assign work, monitor deliverables, and provide timely technical and performance feedback.
• Provide day-to-day Quality Engineering leadership across machining, sheet metal fabrication, and electro-mechanical assembly, including cable, test, and final assembly operations.
• Serve as a hands‑on escalation point for significant product and process quality issues. Establish containment, lead cross-functional problem solving, communicate status and risk, and drive issues to verified closure.
• Act as the Voice of the Customer in internal decisions and actively support customer meetings, technical reviews, quality escalations, complaints, returns, and corrective‑action responses.
• Lead product and process quality planning, including PFMEAs, control plans, inspection plans, critical‑to‑quality characteristics, sampling strategies, capability studies, and Measurement System Analysis/GR&R.
• Support New Product Introduction and manufacturing transfers by ensuring quality requirements, acceptance criteria, process controls, validation plans, and readiness evidence are defined and completed before production release.
• Plan, review, and approve equipment and process qualification/validation activities. Scope includes machining, forming, punching, welding and joining, special processes, inspection equipment, and electro‑mechanical assembly and test processes, as applicable.
• Lead or oversee investigations of nonconformances, customer complaints, audit findings, and adverse quality trends using structured problem‑solving methods. Ensure CAPA and corrective actions address root cause and demonstrate effectiveness.
• Provide Quality Engineering support to the Material Review Board (MRB), including technical assessment, risk‑based disposition, corrective‑action escalation, and reduction of aging nonconforming material.
• Establish and maintain process‑performance metrics for assigned value streams, including yield, defects, scrap/rework, customer escapes, process capability, and cost of poor quality. Use data and statistical methods to identify and drive improvement priorities.
• Partner with Quality Control and Metrology to develop capable and efficient inspection methods, fixtures, programs, measurement systems, and acceptance strategies for incoming, in‑process, and final inspection.
• Partner with Manufacturing Engineering and Operations to improve process controls, error‑proofing, work instructions, manufacturing practices, and production flow while maintaining product conformance.
• Support supplier quality improvement and supplier‑related investigations in collaboration with Supply Chain, including evaluation of supplier performance, corrective actions, and verification of effectiveness.
• Create, review, and approve quality procedures, work instructions, forms, and quality records. Review drawings, routers/work orders, specifications, and engineering changes for complete and executable quality requirements.
• Support maintenance and continual improvement of the ISO 13485 and ISO 9001 Quality Management System and compliance with applicable customer and 21 CFR Part 820 requirements.
• Support internal, customer, and regulatory audits; maintain audit readiness and ensure assigned findings and commitments are completed on time.
• Assess Quality Engineering workload, skills, staffing, tools, and equipment needs. Escalate constraints and recommend practical capacity and capability improvements to the Director of Quality.
• Promote a proactive quality culture through clear expectations, cross‑functional collaboration, employee development, accountability, and fact‑based decision making.
• Provide periodic reports to the Director of Quality and site leadership on product quality, engineering priorities, project status, risks, and key performance indicators.
• Undertake additional responsibilities or activities as required by the Director of Quality.

Requirements

Job Requirements / Skills:

• Bachelor's degree in Quality, Mechanical, Manufacturing, Industrial, Electrical Engineering, or a closely related technical field.
• Seven or more years of progressive Quality Engineering or manufacturing quality experience, including at least three years of technical leadership, project leadership, or people‑management responsibility.
• Experience in a regulated medical‑device manufacturing environment is strongly preferred.
• Demonstrated working knowledge of machining and/or sheet metal fabrication processes. Experience with electro‑mechanical assembly, cable/harness assembly, functional test, welding/joining, plating, painting, or other special processes is highly desirable.
• Strong hands‑on knowledge of ISO 13485 Quality Management Systems. Knowledge of ISO 9001 and applicable 21 CFR Part 820 requirements is desired.
• Demonstrated expertise in PFMEA, control plans, process qualification and validation, equipment qualification, process capability, SPC, Measurement System Analysis/GR&R, and risk‑based quality planning.
• Demonstrated success applying structured problem‑solving methods such as 8D, DMAIC, fishbone analysis, 5 Why, hypothesis testing, and Design of Experiments.
• Working knowledge of dimensional inspection, GD&T, metrology, inspection fixtures, CMM/vision measurement, and the development of robust inspection methods.
• Ability to interpret engineering drawings, specifications, schematics, and customer quality requirements and translate them into practical manufacturing and inspection controls.
• Strong leadership, coaching, communication, and interpersonal skills, with the ability to set priorities and positively influence cross‑functional teams in a fast‑paced manufacturing environment.
• Ability to professionally represent the company in customer, supplier, auditor, and regulatory interactions.
• Proficiency with statistical analysis software such as Minitab or JMP and working knowledge of electronic QMS, ERP, and standard business applications.
• Independent, detail‑oriented, practical, collaborative, and comfortable balancing urgent production support with long‑term process improvement.
• Ability to travel occasionally to customers, suppliers, or other company locations, as business needs require.