Quality Manager- Medical - Johnson Service Group

Johnson Service Group is looking for a Quality Manager for one of our clients in San Jose, CA. The Quality Manager is responsible for all aspects of the Quality and Environmental Management Systems, including the development, implementation, maintenance, and management of quality policies, procedures, processes, programs, and practices that meet established standards, customer specifications, regulatory requirements, and production goals. The Quality Manager may perform a variety of tasks aligned with their training, experience, and skills as assigned by their Manager. This role includes oversight of quality systems for both PCBA/Mechanical EMS environments and medical products, ensuring compliance with relevant medical device standards and regulations.

Essential Functions and Responsibilities:

• Hire, mentor, and manage the team of Quality Engineers, Quality Supervisors, Quality Inspectors, and other staff to meet or exceed all quality control requirements for both electronic manufacturing services and medical product environments.
• Develop, implement, and maintain a robust Quality Management System (QMS) compliant with ISO 9001, ISO 13485, ISO 14001, FDA 21 CFR Part 820 (for medical devices), and other applicable regulatory standards.
• Lead external audits, including those from customers, notified bodies, FDA, and other regulatory authorities, and successfully address/close all findings, particularly for medical products.
• Foster a strong quality control environment, acting as the key point of contact for all quality-related issues. Manage the Quality Control program with a "zero defect" mindset, particularly with respect to medical products, ensuring compliance with stringent regulatory requirements.
• Develop and analyze statistical data and process specifications to determine yields and establish quality standards for both in-process and finished products, including medical devices. Provide technical and statistical expertise as needed, with a focus on meeting medical product safety and efficacy standards.
• Identify, drive, and maintain quality control goals and ongoing objectives, coordinating with Operations and Manufacturing to maximize product quality while minimizing costs, especially for regulated medical products.
• Interface with the Corporate Quality Group on escalations, procedures, reporting, and quality tools, with an emphasis on adherence to medical device manufacturing regulations.
• Take ownership of periodic quality review meetings, driving improvement initiatives at all stages of production for medical products and electronic assemblies.
• Lead the CAPA program, ensuring that true root cause analyses and corrective actions are effectively implemented to prevent recurrence of issues, particularly for medical devices subject to FDA regulations.
• Manage MRB and RMA programs to meet established targets, ensuring minimal waste. Oversee Calibration Programs, ESD Control, NCMR Control, and all other relevant quality control programs, especially for medical products where regulatory compliance is critical.
• Interface with customers to represent the company for both internal and external quality failures, including those related to medical devices.
• Manage and maintain the Environmental Health and Safety program, ensuring compliance with corporate and regulatory environmental requirements for both general and medical product manufacturing.
• Drive continuous improvement initiatives, such as Kaizen projects, Gemba walks, and 5S disciplines, ensuring that medical products meet or exceed all regulatory requirements.
• May be responsible for owning and maintaining Document Control, including management of customer, quality, and production documents, especially those related to medical products that must comply with FDA and ISO 13485 requirements.
• Perform other relevant tasks as assigned.

Qualifications Required:

• Minimum of seven (7) years of experience as a Quality Manager in a PCBA, Mechanical EMS, and Medical Device Manufacturing environment.
• Bachelor’s Degree in a related field or equivalent.
• Experience with ISO 9001, ISO 13485, FDA 21 CFR Part 820, and other regulatory requirements for medical products.
• Proficiency with Microsoft Office Suite, including advanced knowledge of Word, PowerPoint, and Excel.
• Kaizen and Lean Manufacturing techniques; Six Sigma Green Belt or higher.
• Experience with the implementation and maintenance of ISO standards (9001, 13485, 14001), particularly in the medical products space.
• Strong organizational skills, detail-oriented, with the ability to multitask and lead teams.
• Demonstrated leadership abilities, particularly in managing teams focused on medical product quality assurance and regulatory compliance.
• Excellent problem-solving and decision-making skills, particularly in high-stakes, regulated environments such as medical products manufacturing.
• Ability to manage conflicting priorities in a fast-paced environment, while collaborating with business executives and operational leaders to develop appropriate solutions.
• Strong communication skills, with the ability to present information and respond to questions from executives, managers, and employees, especially in relation to regulatory compliance for medical products.
• High integrity in handling confidential and sensitive information, particularly related to regulatory audits and compliance in medical products.
• Self-directed, dependable, and motivated with excellent relationship and time management skills.
• Experience with document control, quality standards, and ISO compliance, particularly in regulated industries such as medical device manufacturing.

Salary starting at $100k DOE
#D800
** 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.