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Quality Engineer

Date: Jul 16, 2021

Location: Dorado, US, 00646

Company: Heraeus

[title]
Quality Engineer
Location Dorado
Permanent  
Full Time
 

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of around 14,800 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.

 
 

In this role you will support process validation activities by ensuring conformance to Heraeus requirements and customer specifications and requirements; and developing robust statistically based inspection methods. Support investigation, evaluation, and disposition of nonconforming product. Support supplier quality activities. Can execute position responsibilities with minimal supervision and direction, with initiative and sense of urgency.

 

Your Role and Responsibilities:

  • Work with different aspects of the Quality Management System to provide support to the entire organization.
  • Manages supplier quality activities. Including, but not limited to: Qualification activities, Corrective Action requests, Audits and Scorecards management.
  • Leads Process FMEA activities.
  • Actively involved with Manufacturing and Engineering in the identification and resolution of product quality problems.
  • Provides primary support for the Nonconforming material and product processes, which includes but is not limited to Disposition, Investigation and CAPA/Corrections
  • Works with internal/external customers to develop inspection methods and process controls for new or existing products.
  • Creates and reviews work instructions associated with inspection methods and equipment.
  • Performs Measurement Systems Analysis (Gage R and R).
  • Utilizes statistical tools to monitor and assess product performance, identification of root causes and continuous improvement of processes.
  • Works with Engineering on product development and pre-production activities. Creates, reviews and/or approves qualification and validation protocols/reports.
  • Supports Change Control activities.
  • Participates and/or assists training activities. Provides training to others based on expertise and demonstrated work experience. 
  • Effectively communicate with external and internal customers (as applicable).
  • Communicates to Quality Manager any potential escapes of non-conforming product to the customer. Actively and timely investigates the scope and evaluates the process controls to determine risk.
  • Participates and supports internal and customer’s audits.
  • As applicable, assures timely response to external customer complaints, quality inquiries and concerns.
  • Provides technical direction to Quality Technicians, as required. May have direct supervisory responsibilities.

 

What is required for this role:

  • BS in Engineering or related field
  • A minimum of 2-5 years’ experience with ISO 13485:2016 standard and/or FDA (CSR 820) regulated industry.
  • ASQ certified Quality Engineer is a plus
  • Ability to utilize ERP software and statistical analysis software.
  • Investigation and root cause analysis strong skill set
  • Project Management, statistical analysis, SPC experience
  • Experience with Six Sigma Tools and 
  • Dimensioning and Tolerancing experience preferred
  • Proficient with Microsoft Office.

 

 

 


Nearest Major Market: Puerto Rico
Nearest Secondary Market: San Juan