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Site Quality Manager

Date: Aug 31, 2021

Location: Concord - California, US, 94520

Company: Heraeus

[title]
Site Quality Manager
Heraeus Medical Components
Location Concord - California
Permanent  
Full Time
 
 

 A member of the Site Management team with responsibility for leading Quality Engineering and Inspection.  The incumbent is responsible for ensuring the desired customer experience through: supporting the process development of product that is manufactured and ensuring conformance to customer specifications and requirements, development of robust statistically based inspection methods, provision of primary support for investigating, evaluating, and disposition of nonconforming product.

ESSENTIAL DUTIES AND RESPONSIBILITIES includes the following. Other duties may be assigned.

  • Develops quality engineering strategies that support the organization’s strategic goals in alignment with the GHMC and HMCA Quality Systems.
  • Supports management of CAPAs and quality systems documentation and ensures timely, accurate, effective execution.
  • Is viewed as the Quality expert who is comfortable engaging with internal employees and external customers.
  • Actively involved with Manufacturing/Engineering in the identification and resolution of product quality problems.
  • Establishes department objectives and works Manufacturing and Engineering closely to assure effective implementation.
  • Ensure support to internal/external customer to develop inspection methods, process controls and standards for new products.
  • .Ensures support for the nonconforming material and product processes which includes but is not limited to Disposition, Investigation, CAPA/Corrections and customer communication.
  • Ensures support of quality inspection team to align priorities with manufacturing and shipping schedules.
  • Supports GHMC Global Quality initiatives and activities.
  • Adheres to the Heraeus Code of Conduct Policy.

 

Education and/or Experience:  BS/BA degree in Engineering or other technical discipline preferred and a minimum of 2 years equivalent work experience in a supervisory or management role and/or 7+ years in QE/QE supervisor role required.Education and/or Experience:  BS/BA degree in Engineering or other technical discipline preferred and a minimum of 2 years equivalent work experience in a supervisory or management role and/or 7+ years in QE/QE supervisor role required.

 

Experience  with ISO 13485 and ISO 9001 standards and regulations.  
Demonstrated experience with statistical analysis. root cause analysis, FMEA, project management, SPC, Six Sigma Tools  and Geometric Dimensioning and Tolerancing. 
Good interpersonal, written and oral communication skills, mentoring, coaching, and strong problem solving skills required.     
ASQ certified QE/CMQ a preferred; Green Belt or greater and Lean certification desired.
 


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland