Quality Documentation Specialist

Quality Documentation Specialist

Speciality: Industrial & Skilled Manufacturing

Location: Salisbury, MA, USA

Type: Full Time

Posted: 01-17-2020

Job Description

Leddy Group

Quality Documentation Specialist

A very successful company in Salisbury, MA that specializes in the manufacturing of healthcare solutions is now seeking to hire a Quality Documentation Specialist to join their growing business.  This position is responsible for the maintenance and documentation of the Quality Control System.

Responsibilities of Quality Documentation Specialist:

  • Assist with the implementation and maintenance of a Quality System based on ISO 13485.
  • Responsible for control of all documentation required for the Quality System
  • Maintain and monitor the status of CAPAs to ensure they are completed as quickly and accurately as possible.
  • Maintain quality system procedures and ensure all necessary documents are properly controlled
  • Implement new inspection, measurement and testing systems for quality monitoring and improvement
  • Conduct Batch Record and record history.
  • Write and/or review protocols and reports for various quality system activities
  • Participate in audit activities including internal, external, supplier, and FDA audits
  •  Perform laboratory or in-process quality testing on devices or components to verify their compliance
  • Ensure associate training is completed according to schedule and assist in the development of the training program

Qualifications for the Quality Documentation Specialist:

  • Associates degree or equivalent Manufacturing work experience
  • Knowledge of ISO 13485 and FDA quality systems
  • Ability to read, comprehend and follow verbal instructions.
  • Very strong administrative skills
  • Experience in MS Office suite and Adobe

This is a Direct Hire position and the pay level does depend upon skills and experience but ranges from $40k -60k.  This is a first shift salary position working Monday through Friday.

Job Location: Salisbury, MA

To apply for this position, please email your resume to seacoast@leddygroup.com, call 603-749-4810 or apply online. Please reference job #40109. 

About Leddy Group:

Leddy Group is a privately-owned regional staffing organization. We specialize in many areas including light industrial, skilled manufacturing, administrative, engineering, executive, human resources, accounting, and finance. View all of our current openings at leddygroup.com.

Quality Documentation Specialist