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Position 3830
Quality Engineer II (Medical Devices)

We are searching for a Quality Engineer II to lead cause-identification and problem-resolution for various types of quality, production or service-related issues in medical devices.

In this role, you will be the primary hands-on investigator for quality complaints. Additionally, you may coordinate complaint resolution with other groups.

Elkton, MD

This role will be performed 80% on site and 20% work from home.

$74K - $85K

Excellent benefits including an annual 8% performance bonus and a 6% 401K match.

Minimum Bachelor's Degree in a relevant discipline such as Mechanical Engineering or Biomedical Engineering

  • Minimum 3 years experience as a Quality Engineer or Process Engineer for a manufactured product in a regulated environment such as medical devices, aerospace components or automotive components.
  • Solid background in addressing quality non-conformance issues on products, root cause analysis, complaint investigation, risk analysis, risk documentation.
  • Experience with Process Failure Mode Effects Analysis (PFMEA) or Design Failure Mode and Effects Analysis (DFMEA).
  • Ability to work cross-functionally with other groups to gather or disseminate information.
  • Experience with Quality Tracking and Trending or Complaint Tracking and Trending tool.

  • Experience working with medical devices including ISO 13485 or ISO 14971

Quality Engineer | Regulated Environment | Medical Device | Process Engineer | PFMEA | DFMEA | 3830

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