Quality Assurance Engineer

  • location: Saint Louis, MO
  • type: Permanent
  • salary: $67,000 - $81,000 per year
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job description

Quality Assurance Engineer

job summary:
Quality Assurance Engineer

  • St. Louis, MO (Central West End)
  • Direct Hire
Job Summary

We are looking for an experienced Quality Assurance Professional, to assist in the development and maintenance of a Quality Management System compliant with 9000. The ideal candidate must have experience with process design, implementation, ongoing audit, and continuous improvement. You must be analytical, self-driven, able to operate in a fast-paced environment, and willing to do what it takes to get the job done.

Responsibilities

In this role, you will tackle a broad range Quality Assurance efforts, including:

  • Provide leadership and guidance in all areas of the Quality Management System, including, but not limited to Corrective & Preventive Actions, Non-conformances, Audits, Document Management, etc.
  • Support Quality Management System development activities through effective communications across all organizational departments
  • Develop procedures for Quality Management System and their implementation.
  • Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions
  • Champion the Quality Department's general FDA compliance activities including compliance auditing and regulatory assistance.
  • Lead quality metrics collection and analysis to drive process improvements.
  • Work as primary contact for customer and external auditors related to Quality
  • Establish and maintain a Quality Management System compliant with 62304, 13485, , FDA 21 CFR Part 820
Required Experience and Skills

  • Bachelor's Degree with 3 years of experience supporting a mature QMS.
  • 3+ years of experience with .
  • 3+ years of experience in process design using in-process controls and sample plans.
  • 9000:2015 Certified Auditor preferred
  • Certified Quality Engineer (CQE) certification and/or certified Six Sigma Green Belt preferred.
 
location: Saint Louis, Missouri
job type: Permanent
salary: $67,000 - 81,000 per year
work hours: 8am to 5pm
education: No Degree Required
 
responsibilities:
Responsibilities

In this role, you will tackle a broad range Quality Assurance efforts, including:

  • Provide leadership and guidance in all areas of the Quality Management System, including, but not limited to Corrective & Preventive Actions, Non-conformances, Audits, Document Management, etc.
  • Support Quality Management System development activities through effective communications across all organizational departments
  • Develop procedures for Quality Management System and their implementation.
  • Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions
  • Champion the Quality Department's general FDA compliance activities including compliance auditing and regulatory assistance.
  • Lead quality metrics collection and analysis to drive process improvements.
  • Work as primary contact for customer and external auditors related to Quality
  • Establish and maintain a Quality Management System compliant with 62304, 13485, , FDA 21 CFR Part 820
 
qualifications:
Required Experience and Skills

  • Bachelor's Degree with 3 years of experience supporting a mature QMS.
  • 3+ years of experience with .
  • 3+ years of experience in process design using in-process controls and sample plans.
  • 9000:2015 Certified Auditor preferred
  • Certified Quality Engineer (CQE) certification and/or certified Six Sigma Green Belt preferred.
 
skills: Required Experience and Skills

  • Bachelor's Degree with 3 years of experience supporting a mature QMS.
  • 3+ years of experience with .
  • 3+ years of experience in process design using in-process controls and sample plans.
  • 9000:2015 Certified Auditor preferred
  • Certified Quality Engineer (CQE) certification and/or certified Six Sigma Green Belt preferred.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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