Quality Engineer in Chester Springs, PA at Volt

Date Posted: 1/17/2021

Job Snapshot

Job Description

Medical Device Quality Engineer

Duties & Responsibilities

  • Lead Quality System enhancements to meet applicable FDA requirements.
  • Lead and mentor factory team’s development of their QMS to align with FDA requirements.
  • Track and evaluate factory performance to determine action required for development and improvement.
  • Champion activity to resolve customer product complaints and issues related to nonconformances.
  • Supports the generation of PPAP documentation such as Control Plans, Process Flow Maps, FMEA, Inspection plans and techniques, GR&R & test requirements.
  • Performs and conducts problem investigations using CAPA processes and RCA tools and methodologies.
  • Coordinates factory process Validation activity as required.

Minimum Qualification

  • BSME or other engineering discipline
  • ISO13485 Medical Device Manufacturing experience.
  • 5 years’ minimum experience in a quality control, assurance and engineering environment.
  • Knowledge of and first-hand experience with FDA / ISO Regulations
  • Experience with Inspection Metrology / GD&T / MSA / manufacturing processes and engineering drawings

Preferred Qualification

  • ISO 13485 / MDD / FDA knowledge and experience
  • ISO 13485 manufacturing environment experience
  • Process Validation experience and involvement
  • Complaint Handling experience

Volt is an equal opportunity employer.