QC Engineering manager

QC Engineering Manager

Indigo is looking to hire

A highly motivated QC Engineering Manager to support the continued quality improvement of Indigo’s operational processes and to
design, implement and execute verification and validation plans and protocols needed to ensure Indigo can measure and assess the quality and performance of its in-process and finished devices.

 

Your main tasks and responsibilities include:

  • Plan, execute and oversee inspection & testing of incoming and outgoing product to confirm quality performance to specifications and quality deliverables.
  • Foster a quality culture in which the company’s employees become engaged in guaranteeing quality in manufacturing and the finished product.
  • Implement, monitor, and analyze quality metrics required to track overall system performance
  • Interface with manufacturing, R&D and product development teams to share data and learnings that can be used to ensure continuous process and design improvement.
  • Coordinate change control & validation projects and ensure that the validation program is performed in accordance with the corporate & internal policies.
  • Develop, review & approve V&V and test method validation protocols & reports.
  • Support the development & execution of equipment calibration & maintenance activities.
  • Support the execution of the equipment qualification & process validation activities by reviewing protocols/reports.
  • Inspect & test materials, equipment, processes, procedures and products so as to ensure quality specifications and safety standards are met.
  • Monitor risk-management procedures and maintain & analyze problem logs to identify and report recurring issues to management and product development.
  • Perform statistical analysis to determine design acceptance, process capability and analyzing trends.
  • Support the different steps of new device development: risk assessment, design control, labeling etc.
  • Investigate & troubleshoot product or manufacturing issues, get to the root cause of technical issues.
  • Ensure that workflows, processes, and products comply with safety regulations.
  • Support the development of new products from concept through commercialization as part of a cross-functional team
  • Act as an SME on quality engineering functions during regulatory audits & inspections

Requirements

  • +10 years of working experience in quality engineering or quality assurance in a micro-electronics, photonics or medical device manufacturing environment
  • + 5 years of experience in a leadership role
  • Degree in quality, industrial, or mechanical engineering
  • Working knowledge of appropriate global medical devices regulations and standards, such as ISO 13485:2016, ISO 14971 and MDR
  • Understanding of medical device manufacturing environment
  • Familiarity with statistical analysis
  • Ability to understand technical drawings & specifications
  • Hands-on experience with QMS and testing methodologies
  • Knowledge of DOE (Design of Experiment), and Minitab statistical software
  • Ability to work with managers & supervisors to implement quality measures
  • Strong leadership and communication skills
  • Strong analytical and troubleshooting skills
  • Fluent in written & spoken English
  • Ability to work in a multidisciplinary and international team environment

What we offer

Together with Indigo’s team of experts, you will work on the development of the first invisible Continuous Glucose Monitor, which will improve the life of so many people living with Diabetes.
You will be part of a fast growing and very international team with plenty of development opportunities.
We offer a very competitive salary, freedom to work independently, a fun-loving and high-performing team and the opportunity to work on one of the defining technologies for the coming decade in diabetes management.

Join us today!

Send us your motivation letter and CV (HR@indigomed.com)
We look forward to hearing from you!