Quality Engineer
JOB DESCRIPTION

The PGDx Quality Engineer will primarily support process improvement initiatives. The Quality Engineer ensures the organization adherence to US/EU medical device regulation, ISO 13485:2016 and other standards/governing regulations applicable to PGDx. Provides a broad scope of technical knowledge in quality system, operations processes, applied statistics and quality tools.

KEY RESPONSIBILITIES
REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor’s Degree in Engineering or Science.
  • Minimum of 2-3 years in medical device manufacturing, within quality engineering function.
  • Ability to identify Quality issues and recommend corrective actions that can lead to resolution of general or routine complexity.
  • Basic knowledge of statistical methods and quality tools, and statistical application software.
  • Strong knowledge in US/EU medical device regulation and ISO 13485:2016 requirements.
  • Strong analytical, organizational, communication, and interpersonal skills are required.
  • Self-motivated, able to work in teams and independent of supervision.
  • Critical thinking ability and attention to detail.
  • Effective technical writing ability and verbal communications skills.
  • Computer skills including MS Office.
ABOUT PERSONAL GENOME DIAGNOSTICS

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@personalgenome.com Special consideration will be given to internal PGDx employees who apply.

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