Quality Engineer III

Job Description

Qualifications

Quality Engineer III

Location: Hercules, CA, USA

Industry: Computer Software
Hours: Contract to Hire
Salary: 50-65hr an Hour

Description: ITG<p> This role is focused on providing expertise and guidance to the business in interpreting and executing against applicable Risk Management, CAPA and Customer Feedback quality system elements. To ensure compliance and certification to ISO 13485 for the LSG QMS during our upcoming surveillance audit with NQA. </p><ul><li>Oversee CAPA program including leading CAPA Review Board meetings, reporting CAPA process metrics and working with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure.</li><li>Advise, coach and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques.</li><li>Present CAPAs during external audits and Quality Review Board Meetings as requested.</li><li>Analyze quality monitoring data sources and apply statistical techniques to ensure that recommendations for the initiation of new CAPA are based on valid statistical methods.</li><li>Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.</li><li>Evaluate and improve QMS procedures and training materials as required.</li><li>Support other quality and compliance activities as required including supporting audits and inspections.</li><li>Bachelor’s degree or equivalent in a related technical discipline.</li><li>5+ years experience or equivalent combination of education and experience.</li><li>Thorough understanding of ISO 13485 and GMP regulations is preferred.</li><li>Quality Engineering, Six Sigma Green or Black Belt Certification preferred.</li><li>Working knowledge of the device/drug/biotech manufacturing process.</li><li>Skilled in statistical methods, statistical process control, and sampling plans.</li><li>Experience working with Power BI and/or Minitab is preferred.</li><li>Understanding of risk management regulations, principles, and application.</li></ul>

Job description:

<p> This role is focused on providing expertise and guidance to the business in interpreting and executing against applicable Risk Management, CAPA and Customer Feedback quality system elements. To ensure compliance and certification to ISO 13485 for the LSG QMS during our upcoming surveillance audit with NQA. </p><ul><li>Oversee CAPA program including leading CAPA Review Board meetings, reporting CAPA process metrics and working with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure.</li><li>Advise, coach and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques.</li><li>Present CAPAs during external audits and Quality Review Board Meetings as requested.</li><li>Analyze quality monitoring data sources and apply statistical techniques to ensure that recommendations for the initiation of new CAPA are based on valid statistical methods.</li><li>Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.</li><li>Evaluate and improve QMS procedures and training materials as required.</li><li>Support other quality and compliance activities as required including supporting audits and inspections.</li><li>Bachelor’s degree or equivalent in a related technical discipline.</li><li>5+ years experience or equivalent combination of education and experience.</li><li>Thorough understanding of ISO 13485 and GMP regulations is preferred.</li><li>Quality Engineering, Six Sigma Green or Black Belt Certification preferred.</li><li>Working knowledge of the device/drug/biotech manufacturing process.</li><li>Skilled in statistical methods, statistical process control, and sampling plans.</li><li>Experience working with Power BI and/or Minitab is preferred.</li><li>Understanding of risk management regulations, principles, and application.</li></ul>

Educational requirements:

  • BS Engineering

Experience requirements:

  • Mid-Senior level

Desired Skills:

  • Risk Management, 5 Years
  • ISO 13485 and GMP regulations, 5 Years
  • Quality Engineering, 5 Years

Qualifications:

Benefits:

No

Incentives:

Date Posted: 2019-04-09 20:57:16

Quality Engineer III

ITG

Hercules, CA, USA

Experience

Mid-Senior level

Industry

Computer Software

Job Type

Contract to Hire

Salary/Hourly Pay

50-65hr an Hour

Education

BS Engineering

Skills

Risk Management, 5 Years ISO 13485 and GMP regulations, 5 Years Quality Engineering, 5 Years

Job description

 This role is focused on providing expertise and guidance to the business in interpreting and executing against applicable Risk Management, CAPA and Customer Feedback quality system elements. To ensure compliance and certification to ISO 13485 for the LSG QMS during our upcoming surveillance audit with NQA. 

  • Oversee CAPA program including leading CAPA Review Board meetings, reporting CAPA process metrics and working with CAPA owners to plan and document investigations, action implementation and effectiveness verification on time and according to procedure.
  • Advise, coach and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques.
  • Present CAPAs during external audits and Quality Review Board Meetings as requested.
  • Analyze quality monitoring data sources and apply statistical techniques to ensure that recommendations for the initiation of new CAPA are based on valid statistical methods.
  • Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
  • Evaluate and improve QMS procedures and training materials as required.
  • Support other quality and compliance activities as required including supporting audits and inspections.
  • Bachelor’s degree or equivalent in a related technical discipline.
  • 5+ years experience or equivalent combination of education and experience.
  • Thorough understanding of ISO 13485 and GMP regulations is preferred.
  • Quality Engineering, Six Sigma Green or Black Belt Certification preferred.
  • Working knowledge of the device/drug/biotech manufacturing process.
  • Skilled in statistical methods, statistical process control, and sampling plans.
  • Experience working with Power BI and/or Minitab is preferred.
  • Understanding of risk management regulations, principles, and application.

Be the first to see Quality Engineer III jobs in Hercules, California
Posted: 04/09/2019
Expires: 05/09/2019
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