Job Title: Manufacturing Quality Engineer

Location: Westford, MA

Duration: 12 Months

Experience Details:

• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
• Own Corrective Action/Preventive Action (CAPA) investigations.
• 2-4 years working experience on similar roles.
• Statistical techniques knowledge (DOE, SPC) is required.
• Computer software knowledge (Microsoft Word, Excel, Power Point).
• Fluency of English (written and speaking) required.
• Desired experience in validation plans for medical industry products and processes and root cause problem solving methodologies
• Knowledge of FDA, GMP and ISO guidelines desired.

Education: Bachelors Degree

Preferred Qualifications:

• Bachelor’s or advanced degree in Mechanical or Biomedical Engineering
• Prior experience with Cardiovascular & Catheter medical devices
• Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.