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Quality Engineer

In California / United States

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Quality Engineer   

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JOB TITLE:
Quality Engineer
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Santa Ana California / United States

JOB DESCRIPTION :

Technical/ Functional Skills

  1. Hands on experience with Medical Devices covering creation of quality and risk plans.
  2. Working knowledge of EU MDR, FDA 21 CFR Part 820, ISO 13485 QMS requirements are must.
  3. Product labelling exposure/understanding preferred
  4. Remediation of the identified of Gaps
  5. Good skills using the tools and techniques of Project Management.
  6. Strong communication skills, both oral and written, to communicate effectively with customers and internal stakeholders
  7. Ability to work effectively in a cross functional team environment and build strong working relationships
  8. Understanding of the vison care products, surgical vision devices and procedures

Experience Required

5+ Years Medical Device Industry Experience

Roles & Responsibilities

  1. Assessment of Labels and Risk Files and create/update appropriate documents.
  2. Identify gaps of Labeling references in all EU marketed Risk files.
  3. Labelling changes coordination and associated change management tasks
  4. Documentation support for EUMDR certification, licenses, and registration, change notification documents, technical file updates
  5. Support for internal quality agreements impact assessments and updates
  6. Compliance activities support: audit assessment and documentation support

Position Details

Apr 17, 2021
S16174661308493402
California / United States
Santa Ana
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Quality Engineer    Apply

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Technical/ Functional Skills

  1. Hands on experience with Medical Devices covering creation of quality and risk plans.
  2. Working knowledge of EU MDR, FDA 21 CFR Part 820, ISO 13485 QMS requirements are must.
  3. Product labelling exposure/understanding preferred
  4. Remediation of the identified of Gaps
  5. Good skills using the tools and techniques of Project Management.
  6. Strong communication skills, both oral and written, to communicate effectively with customers and internal stakeholders
  7. Ability to work effectively in a cross functional team environment and build strong working relationships
  8. Understanding of the vison care products, surgical vision devices and procedures

Experience Required

5+ Years Medical Device Industry Experience

Roles & Responsibilities

  1. Assessment of Labels and Risk Files and create/update appropriate documents.
  2. Identify gaps of Labeling references in all EU marketed Risk files.
  3. Labelling changes coordination and associated change management tasks
  4. Documentation support for EUMDR certification, licenses, and registration, change notification documents, technical file updates
  5. Support for internal quality agreements impact assessments and updates
  6. Compliance activities support: audit assessment and documentation support