Position 3831
Senior Quality Engineer (Medical Devices)

We are searching for a Senior Quality Engineer with experience in ISO 13485 and ISO 14971 regulated device manufacturing.

Elkton, MD

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

$92K - $107K depending on skills and experience.

Excellent benefits including an annual 10% performance bonus and 6% 401K match.

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

  • Several years working as a Quality Engineer or Process Engineer for a medical device manufacturer.
  • Solid experience in a role that is responsible for document reviews, compliance reviews and risk management.
  • Solid experience with ISO 13485 and ISO 14971.
  • Extensive experience with Corrective Action Preventive Action (CAPA) systems.
  • Experience supporting an internal audit.

  • From time to time, this role may be involved in hands-on complaint investigations, however it will primarily focus on documentation review, compliance review, CAPA and risk management.
  • The role will provide post-market reviews, analysis and reports.
  • The role will support internal audits.
  • This role is more focused on quality systems and less on the investigations themselves.

Quality Engineer | Regulated Environment | Medical Device | Process Engineer | PFMEA | DFMEA | ISO 13485 | ISO 14971 | 3831

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