Quality Engineering Manager - Oxenham Group LLC

Position: Quality Engineering Manager

Location: Onsite in Mansfield, MA

Responsibilities:

• Responsible for management of site Quality Engineering activities including:
  • Process and equipment validations
  • Test method validations
  • Deviations
  • Non-conformance and CAPA investigations
  • Product hold management
  • Design/manufacturing change support
  • Test method validations
  • pFMEAs
  • Equipment management
  • Management of key Quality Management System elements including:
  • Control of Nonconforming Product
  • Deviations

Qualifications:

• Bachelor's degree in STEM
• 5-7 years of experience Managing Quality Engineers in the Medical Device Industry.
• Working knowledge of QA Engineering related QMS elements including: Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product, Inspection and Test, Test Method Validations.