Quality Supervisor/Engineering

Incoming Quality Supervisor/Engineer

Quality Supervisor/Engineer

Full-time, salary position on site in Milpitas, CA reporting to the Manager of Production Quality. The Quality Supervisor/Engineer will oversee the incoming inspection, non-conformance, and final quality acceptance processes. This includes inspection planning coordination, material review board, and process auditing.

Core Responsibilities:

• Provide supervision to employees in their respective areas (Incoming Inspection, Non-Conformance, and Final Inspection).

• Provide guidance for incoming inspection criteria

• Coordinate inspection plan and schedule for first article inspection (FAI).

• Manage the material review board process including defect Pareto and trend analysis.

• Facilitate root cause analysis for non-conformances through brainstorming, use of fishbone diagrams, 8D methodologies, CAPA, and design of experiments, etc.

• Participate in the change control process as needed.

• Manage and maintain the calibration program.

• Manage in-process audit program.

• Present operational and quality metrics related to process audits, MRB, and final inspection.

• Maintain Quality Management System

Additional Responsibilities:

• Support the Quality Department objectives and goals by managing or participating in Quality projects.

• Lead and participate in CAPAs as required.

• Support Supplier Corrective Action closure via verification activities.

• Work cross-functionally with other functional departments.

Required Skills and Knowledge:

• ISO 13485 and/or FDA (CFR 820) Medical Device knowledge.

• Ability to effectively interface and communicate with multiple constituents, including senior management, consultants, suppliers, and employees of all levels.

• Ability to grow and mentor peers and direct reports, and work collaboratively across all organizational levels.

• Change agent who accepts and supports new ideas and processes.

• Strongly demonstrated written and verbal communication skills.

• Ability to consistently balance sense of urgency with diplomacy/empathy.

• Strong time management skills and attention to detail.

• Strongly demonstrated organizational and project management skills.

• Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project).

• Team builder, self-starter, organized, and analytical.

Basic Qualifications:

• Bachelor of Science degree

• Minimum of one (1) year of supervisory experience

• Minimum of three (3) years of experience in manufacturing environment

• Demonstrated success in applying quality problem solving methods such as fishbone diagrams, 5-Why, FMEA, process capability analysis, 8D methodologies, CAPA, DoE, SPC, etc.

Preferred Qualifications:

• Experience working with complex electro-mechanical systems

• Experience with broad variety of measurement and quality data analytic techniques

• ISO 13485 and/or FDA (CFR 820) Medical Device knowledge

• ISO 9001:2015 or IATF/TS 16949 experience

• Understanding of AQL levels contained in ANSI standards.

• SAP experience

• Minitab experience

• GD&T knowledge

Work Conditions:

• Office Environment

• May travel up to 10%

Base Compensation: $95,018 to $121,411

(Actual compensation is subject to variation due to such factors as location, education, experience, and skillset. We offer a comprehensive benefits package, including medical, dental and vision plans covering eligible US employees and dependents, voluntary wellness and employee assistance programs, life insurance, disability, retirement plans with matching, and paid time off.)