Johnson Service Group is looking for a Quality Manager for one of our clients in San Jose, CA. The Quality Manager is responsible for overseeing the Quality Management System (QMS) in compliance with ISO standards and regulatory requirements, including ISO 9001, ISO 13485, ISO 14001, and FDA guidelines. This position involves leading audits, managing the Environmental Health and Safety (EHS) program, and implementing continuous quality improvement initiatives. The Quality Manager will lead a team of quality professionals, driving quality control processes, CAPA programs, and sustainability initiatives while working closely with corporate teams to ensure compliance and operational excellence.
Essential Functions and Responsibilities
Audit Management: Represent the company in a variety of external audits (customer, notified body, FDA, fire department) and address/close findings and nonconformities effectively.
Corporate Quality Collaboration: Partner with the Corporate Quality Group for corporate audits, compliance, escalations, data reporting, and quality tools.
Customer Interface: Serve as the primary contact for quality issues, managing both internal and external quality failures and their resolution.
QMS Development and Maintenance: Ensure the Quality Management System aligns with ISO and regulatory standards, implementing new standards as required.
Environmental Health and Safety (EHS) Program: Oversee EHS compliance in collaboration with corporate managers to fulfill environmental, health, and safety requirements.
Team Leadership: Hire, mentor, and manage Quality Engineers, Supervisors, Inspectors, and other staff to meet quality control goals and objectives.
Quality Control: Create a quality-focused environment, establish quality control goals, and maintain the plant’s Quality Control program with a zero-defect mindset.
Data and Process Analysis: Develop and analyze statistical data to assess product quality and work with operations to improve efficiency and reduce costs.
Management Reviews: Prepare and deliver Management Reviews in alignment with company QMS requirements.
Corrective Actions: Lead the CAPA program, utilizing the 8D process to perform root cause analysis and drive permanent corrective actions.
MRB and RMA Management: Manage MRB and RMA programs to meet established targets with a zero-waste approach.
Calibration and Control Programs: Oversee Calibration Programs, ESD Control, NCMR Control, and internal audits to ensure a robust quality system.
Continuous Improvement: Drive Kaizen projects, Gemba walks, 5S disciplines, and sustainability initiatives in alignment with corporate objectives.
Document Control: Maintain customer, quality, and production document control systems as required
Qualifications Required
Experience: Minimum of 7 years as a Quality Manager in a PCBA and Mechanical EMS environment.
Education: Bachelor’s degree in a related field or equivalent experience.
Software Proficiency: Advanced knowledge of Microsoft Office Suite (Word, PowerPoint, Excel).
Certifications and Knowledge: Familiarity with Kaizen, Lean Manufacturing, Six Sigma Green Belt or higher; ISO standards implementation experience (ISO 9001, 14001, or 13485).
Skills: Proficient in developing/documenting procedures, quality inspection techniques, and statistical data analysis.
Organizational Skills: Strong detail orientation, multitasking abilities, and effective leadership.
Communication Skills: Excellent presentation and interpersonal skills, with the ability to work in a fast-paced, high-stakes environment.
Salary starting at $100k DOE
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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