Quality Engineer

  • location: West Columbia, SC
  • type: Permanent
  • salary: $70,000 - $80,000 per year
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job description

Quality Engineer

Permanent position: Quality Compliance Specialist needed at rapidly growing manufacturing plant located in West Columbia, SC. This is a day shift role. APPLY NOW!

Responsibilities for the Quality Engineer
  • Assure the conformance of all organization's regulatory and quality systems requirements.
  • Site admin for QDMS system
  • Site contact for all regulatory audits..
  • Perform internal audits to verify compliance and conformance to all regulatory and quality systems requirements
  • Engage in external audit processes (Customers', Regulatory, Government Agencies, etc.)
  • Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures in the organization.
  • Develop training programs for internal users in subjects related to Regulations or Quality Systems
  • Execute the formation of Regulatory and Quality Systems skilled employees that help support the organization.
Requirements for the Quality Engineer

  • Knowledgeable and experienced on Quality Management Systems (QMS).
  • Must have medical device experience and be knowledgeable in ISO 13485
  • Knowledgeable and experienced in performing internal audits.
  • Site liaison, coordinator, lead for all current and future regulatory agencies.
Benefits

  • Full range of medical benefits, dental, vision
  • Life Insurance
  • Matching 401K
  • PTO
  • Tuition Reimbursement
  • Employee discounts at local retailers
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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