Quality Manager

3 weeks ago

Milpitas, California, United States Employnet Workforce Solutions Full time
Job Title: Quality Manager - Medical

Job Summary:

The Quality Manager - Medical is responsible for leading the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 9001, ISO 13485, and FDA regulations. This role involves managing a team of quality engineers, supervisors, and inspectors to ensure compliance with quality control requirements.

Key Responsibilities:

  • Develop and maintain the QMS, including quality policies, procedures, and processes.
  • Lead external audits, such as customer and notified body audits, and address findings successfully.
  • Create a strong quality control environment and manage the Quality Control program with a zero-defect mindset.
  • Develop and analyze statistical data to determine yields and establish quality of in-process and finished products.
  • Identify, drive, and maintain quality control goals and objectives, and coordinate with Operations and Manufacturing departments to maximize product quality and minimize costs.
  • Interface with the Corporate Quality Group for escalations, procedures, reporting, and quality tools.
  • Drive the CAPA program, help internal and external teams to drive true root cause analysis and corrective actions, and manage the MRB and RMA programs.
  • Oversee Calibration Programs, ESD Control, NCMR Control, regular Internal Audits, and other areas and programs relevant to a robust quality control system.
  • Interface with customers to represent the company for internal and external quality failures.
  • Manage and maintain the Environmental Health and Safety program, and closely work with Corporate managers to fulfill environment, health, and safety requirements.
  • Drive sustainability projects under the guidance of Corporate directives and cover the plant in corporate and customer audits.
  • Drive continuous improvement for the organization, including Kaizen projects, Gemba walks, and 5S disciplines.
  • May be responsible for owning and maintaining the Document Control, including the full management and control of customer, quality, and production documents.

Qualifications:

  • At least seven (7) years of experience as a Quality Manager in a PCBA and Mechanical EMS environment.
  • Bachelor's Degree in a related field or equivalent.
  • Proficient with PC-based software, including Microsoft Office Suite, and advanced knowledge of Word, PowerPoint, and Excel.
  • Kaizen and lean Manufacturing techniques, 6 sigma green belt or better.
  • Direct management and bring-up of at least one (1) ISO standards implementation.
  • Experience with developing and documenting procedures.
  • Use of quality engineering methods in inspection.
  • Strong, effective organizational skills, detail-oriented, and ability to multitask.
  • Demonstrated effective leadership abilities.
  • Ability to effectively present information and respond to questions from executives, managers, and employees.
  • Possess a high level of integrity in handling confidential and sensitive information.
  • Self-directed, dependable, and motivated with excellent relationship and time management skills.

Work Environment:

The Quality Manager - Medical will work in a fast-paced environment, requiring the ability to manage conflicting priorities, partner with business executives and operations leaders, and develop appropriate solutions. The role involves regular communication with internal customers, auditors, employees, and management, and requires a high level of integrity in handling confidential and sensitive information.

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