Quality Engineer – Roanoke, VA

Quality Engineer

P1 Technologies

Roanoke, VA

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Job Description

The Quality Engineer will work directly with the Production and Engineering teams to assure products conform to quality standards and establish compliance with the quality system. The Quality Engineer is also responsible for maintaining a strong, collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Responsibilities

  • Leads CAPA investigations, including root cause analysis and corrective/preventive action determination and implementation
  • Leads periodic Failure Review Board meetings
  • Conducts and leads non-conformance risk assessments
  • Identifies and drives manufacturing process improvements

Education/Experience Requirements

  • Bachelor’s degree in Process Engineering or a related field required
  • Minimum 2-3 years of experience working in the medical device or other regulated industry preferred
  • Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements
  • Understanding of Risk Management practices, including FMEA
  • Strong understanding of statistical techniques
  • Strong understanding of Root Cause Analysis techniques
  • Experience with Process Validations

Expected Areas of Competence

  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.)
  • Ability to deliver, meet deadlines and have results orientation
  • Strong analytical and problem-solving skills

P1 Technologies is an EOE

Job Type: Full-time

Salary: From $70,000.00 per year

Benefits:

 

  • 401(k)
  • Dental Insurance
  • Health insurance
  • Paid time off
  • Vision insurance

 

 

Supplemental pay types:

 

  • Bonus pay

 

 

 

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