Quality Engineer-Medical Device in Chester Springs, PA at Volt

Date Posted: 7/30/2021

Job Snapshot

Job Description

Medical Device Quality Engineer

The Medical Devices Quality Engineer will help lead our expansion into the Medical Device industry while supporting our principles of and commitment to continual improvement. This QE supports all department activity with a focus on QMS compliance and further development into the Medical Devices industry. Responsibility includes documenting systems enhancements for devices compliance and involvement with customer and factory teams to meet expectations, process and manufacturing commitments. This role requires customer relationship building, partnering in addition to interacting with all team members related to product design review, manufacture, production, trouble-shooting, corrective action and continual improvement.

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.