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Quality Engineer

Sherwood Forest, CA 91325

Posted: 01/17/2023 Employment Type: Contract Job Category: Engineering Job Number: 538495 Is job remote?: No Country: United States

Job Description

HM's Needs
  1. Medical device experience
  2. Directly supported manufacturing either in an operations role or quality engineering
  3. Continuous improvement

Must Have
1. Investigation and root cause analysis skills
2. Technical writing knowledge. Organization and Communication skills
3. Process Validation and Computer software validation knowledge
4. Solid understanding of engineering fundamentals, strong troubleshooting skills for mechanical and software systems

Nice To Have
  • Test Method Development and Validation
Education Required: Bachelors

Years’ Experience Required: 5-20


A Day in the Life

The Diabetes Sensor Operations Team is looking for an independently driven Senior Quality Engineer (QE) to serve as technical resource for our sensor operations manufacturing team.

The Senior QE will ensure our manufacturing lines are running effectively and actively looking for opportunities to improve productivity and quality while decreasing product variability. Once identified, you will be responsible for bringing these meaningful process improvements to fruition which includes leading kaizen projects for sensor fabrication and assembly manufacturing operations. Your work will directly contribute to our goal to produce the highest quality products that transform the way people manage diabetes around the world.

You will be responsible for day shift operations ensuring production is operating continuously through efficient resolution of documentation, material, and equipment incidents.

You will become the day shift liaison between production and engineering management to provide production updates and escalate issues when necessary.

You will author production documents, templates, reports, and specifications.

You will author equipment protocols and conduct qualifications/validations.

You will be responsible for equipment/process/product non-conformances providing a thorough root cause investigation and effective corrective actions.

You will develop innovative and novel ideas to tackle recurring challenges on the production floor.

You will interact with production personnel to provide training, collaborate on improvement concepts, and assist with production flow.

You will partner with New Product Introduction teams to develop and execute calibration, process validation (IQ/OQ/PQ) and Test Method Validation (TMV) protocols/report.

You will utilize your knowledge of six-sigma/lean best practice tools to deliver efficient manufacturing cells that enable the company to exceed its targets.

  • Candidate will have an engineering, biomedical, or sciences degree through an accredited university.
  • Candidate will have a minimum of 5 years work experience.
  • Candidate preference to have a background in medical device/pharmaceutical/aerospace industry.
  • Candidate preference to have background in regulated manufacturing industries.
  • Candidate preference to have lean six sigma experience.
  • Candidate preference to have experience using document control software such as Agile.
  • Candidate preference to have experience using Quality software such as Trackwise.
  • Candidate preference to have experience using SPC tools like Minitab.
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