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Quality Assurance Engineer

2 months ago

Medina, New York, United States Rose International Full time
Job Summary

Rose International is seeking a highly skilled Principal Engineer, Quality Validation to lead our quality assurance efforts. As a key member of our organization, you will be responsible for ensuring the highest quality standards are met in the medical device industry.

Key Responsibilities:
  • Develop and execute validation protocols (IQ, OQ, PQ) for products, processes, and equipment
  • Manage non-conformance reports and use formal problem-solving tools for corrective and preventive actions (CAPA)
  • Lead internal auditing, Six Sigma Certification (Green or Black Belt preferred), and team development
  • Provide metric reports to management during reviews and reports
  • Implement quality programs and establish quality assurance measures at all key stages of manufacturing
  • Review manufacturing, purchasing, and test documentation to ensure requirements are fulfilled
  • Develop procedures for production testing and standardize inspection methods
  • Promote and train personnel to ensure awareness of regulatory and customer requirements
  • Act as a technical team leader and support operations with quality issues/root cause analysis/corrective actions
Requirements:
  • 5-8 years of experience in the medical device industry in development and deployment of Quality Systems, implementing process controls, and continuous improvement methodologies
  • Knowledge and working application of FDA cGMP, ANSI/ISO/ASQC, and CMDAS requirements
  • Knowledge and working application of validation principles and guidelines and industry practice
  • Knowledge and working application of PFMEA and Risk Analysis
  • Knowledge and working application of reading and understanding blue prints and technical drawings
  • Knowledge and working application of standard operating procedures
  • Display a solid technical understanding of engineering principles and procedures
  • Understand and articulate how own role ties within function or discipline
  • Demonstrated strong analytical problem-solving, teaming, and communications/interpersonal skills
Preferred Qualifications:
  • CQE, CSSBB, CQA, or initiative to complete certifications
  • Experience with TQM methods (e.g. 'six sigma')
  • Internal Quality System auditing experience (ISO 13485 and FDA 21CFR820)
  • Computer competency in Word, Excel, Power Point, Minitab, Access, and databases
Education/Experience:
  • Bachelor's degree in Engineering
  • 5-8 years of related experience
  • Six Sigma Certification (Green Belt or Black Belt) is desirable

Rose International is an Equal Opportunity Employer. We are committed to diversity and inclusion in the workplace. If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, please contact our HR Department.