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Quality Engineer

Medical Device in St Louis are currently looking for an experienced Quality Engineer to join the quality team for a permanent direct hire role. The company produces glass cartridges (as a drug delivery device) and is seeking a Quality Engineer who has experience with glass manufacturing.

As the Quality Engineer you will partner with the glass vendors on all areas of quality. You will manage quality data & metrics, work with the vendors on SCARs, continuous improvements projects & increase capabilities. You will also work with internal production on glass processing, visual inspection and automated vision systems.

Responsibilities:

  • Designs, executes Quality Engineering related protocols; and summarizes studies to ensure consistency of data production and compliance with manufacturer and specifications with current Good Manufacturing Practices.
  • Responsible for quality and process related issues for outside suppliers.
  • Responsible for assisting in creating all applicable process documentation to guarantee production processing consistent within validated parameters.
  • Evaluates equipment or process problems (internal and at suppliers as needed) and designs testing to determine possible causes or solutions; assists in determining process capability of new equipment. May also be called on to harmonize measurement techniques between the site and supplier.
  • Assists in ensuring product development activities have all necessary Quality Engineering supporting justifications.
  • Interacts with third party customers, outside testing laboratories and provides Quality Engineering assistance where needed on specific issues.
  • Assists in identifying root causes and coordinate corrective action to quality issues in Packaging and Inspection and the Sterile Facility.
  • Quarantine product or components as necessary.
  • Assist SQC lab supervisor with technical issues involving injector functionality, component testing, and protocol execution.
  • Assists in compiling quality data, which includes: gage R&R studies, process capability studies, trending of product defects, trending of functionality data for finished product, dimensions on components or finished product, raw material inspection/sampling, incoming component inspection.
  • Training inspectors, SQC technicians, and supervisors on the following: new procedures, new equipment, new measurement methods, new inspection criteria, Component/product defects and failure modes.

Requirements:

  • BS in an Engineering related field
  • 4 years Quality Engineering experience in the medical device or pharmaceutical industry
  • 3 years of experience with glass manufacturing processing. Ability to assess glass defects and make recommendations of glass production & processing.

This is a permanent direct hire role. So you will need to be a US citizen or green card holder to be eligible to apply.

Salary is depending on experience, up to $100K + bonus, insurance and relocation package if you are not currently in the St Louis area.

If you are interested and meet the requirements, please apply with your resume.

Sthree US is acting as an Employment Agency in relation to this vacancy.