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Company Name:
AtriCure
Approximate Salary:
Not Specified
Location:
Cincinnati, Ohio
Country:
United States
Industry:
Position type:
Experience level:
Education level:

Quality Specialist (Contract)

Position/Title: Quality Specialist (Contract)

Department: Quality

Reports To: Manager, Quality Engineering

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator SynergyTM Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

Position Summary:

This is a technical position focused on completing directed tasks in support of larger projects. This role assuming various years of experience and different job roles. The job performance requires solid technical abilities as well as an understanding of product design, manufacturing and quality systems. The Quality Specialist works closely with AtriCure engineering, manufacturing, quality, and/ or suppliers to ensure that directed tasks and quality system activities are completed. This individual will have a technical foundation and must be able to complete and coordinate activities related to projects. This individual will operate regularly with a cross functional team and contributes to the creation of a collaborative work environment.

**This is a contract position for approximately 6 months.

Roles and Responsibilities:

  • Provides Quality support of manufacturing operations and quality systems where daily activities require working with collaborative cross-functional teams.
  • With respect to direct line responsibility, the QE manages and coordinates required activities from functions (ie. Engineering, Manufacturing, Quality, Inspection, Document Control) and processes (ie. Risk Management, Manufacturing Documentation, CAPA, Change Notices, Labeling Configuration, Validation, etc)
  • Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, seeks guidance from peers or management as appropriate to resolve problems / conflicts.
  • Contributes to design / manufacturing transfer by supporting Design Assurance (and NPD Teams) as required.
  • Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.
  • Performs other duties as assigned.

BASIC QUALIFICATIONS:

  • 1 - 3 years of experience in a technical role (manufacturing, process, quality engineering, or equivalent)
  • Bachelor's degree in engineering or equivalent
  • Able to interpret design drawings and product specifications
  • Problem Solving/Troubleshooting experience
  • Possesses interpersonal, organizational, and communication skills.
  • Verbal communication and people skills
  • FDA and ISO 13485 knowledge
  • Data analysis experience
  • Computer/data entry skills
  • Written/report writing skills (technical writing)

PREFERRED QUALIFICATIONS:

  • Metrology background
  • Gage R&R experience
  • Medical device design control experience
  • Medical device labeling experience
  • MDD, MDR, CMDR and JPAL knowledge
  • ASQ Certified Quality Engineer (CQE)
  • Familiar with EO and Gamma sterilization processes.
  • Experience with industrial or manufacturing statistics
  • Regulatory experience
  • Engineering/design background

ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %; O=Occasional, R=Regularly, N=Never):

  • Regularly walk, sit, and stand
  • Occasionally bend and push/pull
  • Occasionally lift over 25 pounds
  • 15% travel potential
  • Position dependent upon candidate passing pre-employment physical/drug screen

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.

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