Quality and Documentation Specialist

Quality and Documentation Specialist

Speciality: Administrative & Office Support, Engineering, View All Jobs

Location: Seabrook, NH, USA

Type: Full Time

Posted: 04-09-2021

Job Description

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Leddy Group

We have a full-time, direct hire opportunity for a Quality and Documentation Specialist in the medical device industry! In this role, you will be responsible for all controlled documentation, such as drawings, procedures, and product structures. This position is located in Seabrook, NH, and works Monday through Friday, 7am-4pm.

Responsibilities of the Quality and Documentation Specialist

  • Administer the Document Change Order (DCO) system and coordinate the preparation and review of DCOs
  • Maintain records related to DCOs and ensure they are up to date and adequately controlled
  • File, retrieve, update, and organize documents
  • Interface with other departments to ensure all document updates are correct and clear
  • Check and release engineering drawings utilizing AutoCAD
  • Enforce departmental and companywide ISO, cGDP, and cGMP requirements
  • Manage configuration, including Device Master Records, revision control/history, etc.
  • Assist in verifying equipment and/or manufacturing processes
  • Assist with Quality Control job functions when needed
  • Perform and schedule equipment calibration and maintenance, and keep up-to-date records on such

Qualifications of the Quality and Documentation Specialist

  • Understanding of design and drafting standards
  • SOP knowledge for Medical Devices/Pharma
  • Prior experience working with the FDA and in a complaint investigation
  • Working knowledge of ISO 13485 at latest revision

If you have the required skills and experience and are also thorough and organized, consider this great Quality and Documentation Specialist opportunity!

To apply, email an MS Word copy of your resume to kpalmer@leddygroup.com, see our website at www.leddygroup.com or call 603-766-2004.  

Quality and Documentation SpecialistAbout Leddy Group

We are Leddy Group . . . a privately owned, regional staffing company serving NH, ME, VT & northern MA since 1994. We are one great brand with multiple specialties:  accounting & finance, administrative & office support, engineering, human resources, industrial, skilled manufacturing, legal, and nonprofit.

At Leddy Group, we combine a consistency of values and traits with a singular standard for quality and best practices. We hold each other accountable to those standards, measure success by the quality of our outcomes, and establish goals based on continuous improvement metrics. We utilize a methodology and process to assess skills and experience; however, identifying the right “fit” is equally important for both candidates and clients alike. Our goal is to exceed your expectations. Our success is tied directly to your satisfaction.