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Sr. Technical Supervisor - Med Device Mftrg and Quality

Carlsbad, CA

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Description

This RemX client is a leading contract manufacturer of medical devices and advanced manufacturing solutions to the medical device and life sciences industries.

Their dramatic growth has created an opportunity for a Senior Technical Supervisor to join their select team in Carlsbad, CA. 

In this role, you will establish and direct the project team regarding Quality requirements, to provide the most efficient end to end project implementation from part concept through first production order including assembly transfer.

This is a strategic, high-visibility position with strong career advancement potential, offering competitive compensation and excellent company benefits.

RESPONSIBILITIES

  • Directs quality assurance activities for all current and future medical/ commercial products.
  • Enacts and manages Quality elements of transfer to manufacturing to include formal documentation and implementation of process flow, risk analysis (PFMEA), control plans, inspection plans, measurement fixtures, and measurement correlation.
  • Provides Statistical Analysis for the associated quality activities and assist in Metrology activities.
  • Enacts and manages Master Validation activities, including IQ, OQ, PQ; measurement system analysis, gage R&R, and measurement correlation.
  • Provides Statistical Analysis for the associated quality activities and assist in Metrology activities.
  • Establish and update Quality Systems based on changes to pertinent regulations, audit observations and changes to existing products and processes.
  • Manage and perform activities associated with CAPA, SCAPA, Supplier Quality, Complaints, Non-Conforming Materials, Inspection and Calibration.
  • Provide assistance to Manufacturing on continuous improvement opportunities.
  • Propose regulatory strategy for new and modified products.
  • Weekly/monthly reporting (local and corporate teams) on key process indicators.
  • Develop and establish SOP's according to regulatory requirements.
  • Oversee qualification and management of overall Supplier base.
  • Lead and facilitate Kaizen teams.

Job Requirements

  • Bachelors and/or advanced degree in a science or technical area or equivalent
  • 5 - 8 years industrial experience, preferably in high volume injection molding, automation and quality principles within medical device industry with demonstrable skills in project management, critical path analysis, injection molding theory, equipment, tooling, materials, assembly and/or processing
  • Knowledge of Lean Six Sigma, Lean Manufacturing principles
  • Medical device experience preferred
  • Strong fundamental understanding of FDA CFR 21 on the ISO 13485 requirements
  • A CQE is preferred but not required.
  • ERP/MRP systems
  • Engineering software – MiniTab
  • Lean Six Sigma Green Belt certification preferred.
  • Lean Six Sigma Black Belt certification a plus.
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