Roles & Responsibilities:

  • Ensure compliance to internal and external management systems to include API and ISO standards and requirements.
  • Develop, implement and maintain procedures for inspections and testing in compliance with the Quality Management System (QMS).
  • Assist in defining and developing quality program status indicators and performance measurements.
  • Provide trend analysis on quality issues and performance metrics.
  • Conduct audit processes internally and at suppliers, including planning, preparation, execution, reporting results, and remedial work plans. Specific audits include ISO and API certifications.
  • Continuously improve knowledge of customer expectations, supplier relations, risk management and improvement, industry standards, business systems, and planning and quality tools.
  • Develop and implement internal Quality Control Plans (QCP) including customer- and project-specific QCPs. Participate in design reviews and criticality assessments of processes as input to QCP development.
  • Investigate and address product non-conformances, working with relevant subject matter experts as needed.
  • Contribute to Quality Improvement Plans.
  • Acquire and analyze data across a spectrum of business environments to facilitate process analysis and improvements. Use metrics, reporting and process control tools to track, analyze and problem solve.
  • Utilize statistical quality tools and techniques to lower total quality costs.
  • Coordinate deviation and non-conformance processes and ensure corrective and preventive actions address fundamental causes.
  • Create and classify Product Quality (PQ) incident reports. Lead and coordinate PQ investigations.
  • Provide QMS training and ensure appropriate competency levels are maintained.

Minimum Job Qualifications

  • Degree in Industrial Engineering, Manufacturing Engineering or similar (BSci minimum)
  • Lean & Six Sigma certified (or proven experience)
  • Minimum of 3 years working in the area of quality assurance and quality control
  • ISO and API Audit experience
  • Must be able to legally work and reside in the US without sponsorship