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Sr. Quality Systems Engineer

Req ID: J2257997

  • 地点
    费利蒙,加利福尼亚州, 加利福尼亚州, United States of America
    利弗莫尔, 加利福尼亚州, 加利福尼亚州, United States of America
  • 类别 质量
  • 发表 2021年1月7日
  • 类型 全职工作

职位描述

JOB SUMMARY

 

The Senior Operations Quality Systems Engineer position owns the implementation and maintenance of the Jabil Quality Management System processes, procedures, and tools.



ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Understanding all Jabil and Fremont QMS processes and procedures

2. Working with the site Quality Manager, defining and establishing a suitable site Quality Systems organization structure

3. Performing QMS gap assessments against:

  • Jabil and Fremont QMS process, procedure, and tool requirements
  • ISO 9001:2015 requirements
  • Site Customer requirements
  • Applicable Statutory and Regulatory requirements
  • Resource adequacy

4. Coordinating QMS Gap Closure:

  • Creation of a Gap Closure Plan with action / process owners and timelines agreed with the site management team
  • Identifying resource needs: local, regional, global (e.g. IT), and external (e.g. third party). Act as the liaison with regional, global and external supports.
  • Action implementation and effectiveness verification
  • Weekly reviews and updates of the Gap Closure Plan with the site management team
  • Weekly reporting to the site Leadership Team.

5. Ensuring site employees are trained to Jabil and Fremont QMS processes, procedures and tools (e.g. Global CAPA and Audit System, PCMS, GDC) 6.

6. Establishing Site Quality Systems KPIs and continuous improvement program (e.g. routine value-added status / working meetings with process owners, management reviews, action plans).

7. Establishing effective Site Internal Audit Program:

  • Developing a cross-functional team of internal auditors
  • Conducting internal audits
  • Initiating corrective and preventive actions, supporting resolution and monitoring closure
  • Verifying CAPA effectiveness with follow up audits

8. Maintaining site Quality Management System ISO 9001:2015 Certification:

  • Scheduling and coordinating third party audits
  • Addressing eventual non-conformities with CARs within 60 days
  • Goal: 0 Systemic breakdowns / Major non-conformities

9. Partnering with site functional leadership team in conducting bi-annual Management Reviews, facilitating:

  • MR presentation development
  • Capturing MR actions.  Then supporting, monitoring, and verifying effective, timely action closure

10. Institutionalizing a robust site Doc Control System:

  • Aligning with Critical Manufacturing (CM) and supporting migration accordingly
  • Inclusive of maintaining latest revisions of Customer documents

11. Function as site Records Custodian, establishing and maintaining an effective site Records Control System:

  • Storage, identification, retrieval of electronic files as well as hardcopy files by destruction year
  • Develop Functional Records Custodians Team and program

12. Performing random process walks to verify / address compliance to defined processes (e.g. JOS, LPA, QRQC, MRB, PM, Calibration, IQC, OBA, Firewall QC, Records, 6S, Handling, Storage, employee qualification to perform role, etc.)

13. Developing Quality Systems staff to effectively perform to their roles and responsibilities
JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS

  • Able to effectively communicate verbally with good writing skills Spanish a plus
  • Experienced Quality Systems leader with proven history of developing and implementing Global Quality processes
  • Quality experience leading ISO 9000 systems
  • Ability to translate customer and business needs into value added quality process in operations, engineering and business services
  • Proven experience in 3 Way 5 Why, CAPA, 8Ds, Problem solving, advanced quality tools, FMEAs, control plans, process control, capability analysis
  • Proven experienced in Mechanical Operations (e.g. Semi-Cap) Quality Management Systems, Quality Engineering, and QMS Integration
  • Experienced Quality Management Systems and manufacturing process auditor with a track record of both identifying system gaps and then closing them
  • Successful history leading change management (i.e. AQP, APQP, IQ/OQ/PQ, Project Management)
  • Must be an outstanding communicator and team facilitator
  • Extremely results oriented with a bias towards action
  • Excellent problem solver. Makes decisions based on data.
  • Ability to identify the salient business and quality issues and focus the team on the critical few actions required for success
  • Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required

EDUCATION & EXPERIENCE REQUIREMENTS

  • Bachelor's Degree in (Engineering) or similar discipline required.
  • Minimum of 4 years work-related experience required in Quality Management.
  • Six Sigma Green Belt or Black Belt preferred
  • Mechanical manufacturing / operations management experience Or an equivalent combination of education, training or experience.
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