Quality Manager in Billerica, MA at Volt

Date Posted: 1/7/2021

Job Snapshot

Job Description

Quality Manager

The candidate will support new product development as well as sustaining product. The ideal candidate will have experience in an ISO and FDA regulated environment. Responsibilities include but are not limited to:

  • Management Representative for ISO 13485
  • Manage Inspection Group
  • Preform and manage Internal Audit Program
  • Perform/Assist with validation (IQ/OQ/PQ) on equipment and process with Engineering
  • Manage Complaint/Feedback System
  • ECO generation and implementation on Procedures and WI
  • Manage CAPA generation and Implementation
  • Manage company metrics for Key Process Indicators (KPI)
  • Assist with MRB dispositions
  • Work with engineering regarding Risk Management activities (PPAP programs, PFMEA’s, Control Plans, etc.)
  • Identify process problems and implement corrective actions via continuous improvement meetings
  • Calibration maintenance
  • Assist with Supplier Maintenance (ASL, Supplier files, etc.)
  • Assist Operation with training as needed
  • Perform CPK analysis as needed on select process

Qualifications

  • Bachelor of Science in Engineering required
  • 5-10 years of medical device experience required
  • Regulatory experience a plus
  • CMM experience a plus

Volt is an equal opportunity employer.