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Quality Manager

Location: Pleasanton, California, United States
Job ID: R0003490
Date Posted: Jul 14, 2021
Segment: Others (Including Headquarters and R&D )
Business Unit: Hitachi Regional Headquarters
Company Name: Hitachi America, Ltd.
Profession (Job Category): Engineering & Science
Job Type (Experience Level): Management
Job Schedule: Full time
Remote: No

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Description

Quality Manager

Company: Hitachi Particle Engineering and Services, Inc.

Department: Engineering Department, AccSys Technology Division

Location: Pleasanton, CA

Status: Regular, Full-Time

Job Summary:  

The Quality Manager is responsible for development and maintenance of quality system to ISO9001 standards, procedures, and quality controls to ensure that products consistently meet performance and quality specifications. Quality Manager is responsible for managing, coordinating and administering all functions of AccSys Quality Management System. Quality Manager is also responsible for getting AccSys ISO 9001 certified and maintain the certification. The Quality Manager is a leader and strong technical resource who quickly, effectively, and permanently resolves quality problems with internal and external customers and suppliers.

Essential Duties and Responsibilities:  

1 ISO System Development and Maintenance (60% of time spent)

1.1   Develop quality specifications, test plans, procedures, tools, and meaningful metrics to control all aspects of manufacturing

1.2   Conduct internal audits, company representative for any customer audits and host management review meetings

1.3   Producing statistical reports on quality standards and quality metrics

1.4   Complying with ISO accreditation requirements

1.5   Understand customer needs and requirements to develop effective quality control processes

1.6  Ensuring quality team achieves established goals and objectives relating to implementing, sustaining & improvement of effective and efficient Quality systems

1.7   Assessing trends & publishing departmental metrics in compliance with AccSys KPI’s. Maintains Quality systems continuous improvement project tracking and report status monthly

2.   Manage Test, Inspection and FAT reporting activities (20% of time spent)

2.1   Ensure that products shipped meet quality performance standards and are, in compliance with customer requirements and AccSys quality perspective

2.2    Take a leadership role on customer complaints to identify, coordinate and effectively resolve problems in a timely manner

2.3    Supervise and provide direction to returned material area to ensure RMA process is working effectively

3.   Support Activities – Calibration, Supplier Monitoring etc. (20% of time spent)

3.1     Manage and monitor Calibration activities

3.2     Review Supplier performance on a timely basis

3.3     Work to quickly and permanently resolve supplier quality issues

3.4     Ensures company policies and procedures are followed & ensures these are enhanced as needed in achievement of divisional goals & objectives

4.  Safety Responsibilities (Select category appropriate for position)

Department Management

  • Support safety goals established by the Company
  • Ensure compliance and enforcement of safety rules
  • Ensure that staff completes required safety training
  • Complete all required safety training
  • Support the Safety Committee and its activities
  • Ensure that unsafe working conditions are reported
  • Ensure that on-the-job safety training is provided to staff
  • Ensure that the required PPE is provided to staff
  • Ensure tools and equipment are safe and properly maintained
  • Ensure that all incidents/accidents are reported, no matter how minor  they may seem
  • Demonstrate role model behavior for safety
  • Maintain awareness and compliance with all current local, state, and federal Environmental regulations
  • Ensure a clean, safe work area for staff in compliance with company and OSHA standards

5.  Performs other duties or special projects as required or as assigned by a supervisor

REQUIREMENTS

Educational/Training/Certification Requirement:  
•    BSC/BA degree in a relevant field
•    Proficient in MS Office
•    Attention to detail

Experience:  
•    Minimum 10 years’ experience as a Quality Manager in a medical device company
•    Minimum 5 years’ experience in managing at least 5 employees


Licenses/Certifications:  
•    ISO Internal Lead Auditor Certification

Knowledge, Skills & Abilities:

•    Employee Education/ Training

•    Reading Mechanical Drawings

•    Written and verbal communication skills

•    Auditing

•    Multi-tasking

•    Conflict Resolution

•    Ability to lift approx. 25 lbs. weight

•    Excellent analytical abilities

•    Ability to adapt, improvise and problem solving

Equal Opportunity Employer (EOE)-Females/Minorities/Protected Veterans/Individuals with Disabilities

If you need a reasonable accommodation to apply for a job at Hitachi, please send the nature of request and contact information to [email protected] Queries other than accommodation requests will not be responded to.

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