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Quality Systems Specialist

Employer
Barrington James
Location
Boston, Massachusetts
Salary
Negotiable
Start date
28 Sep 2022
Closing date
28 Oct 2022

View more

Discipline
Quality, Systems Manager
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Quality Systems Specialist

12-15 Month Contract

 

Barrington James Recruitment has partnered with a Medical Device company that is a leader in developing innovative solutions for treatment of advanced heart diseases.

The Quality Systems Specialist is responsible for the proper control of documents, quality records and training in accordance with ISO 13485 and applicable regulatory requirements.

 

Responsibilities;

 

Document Control

  • Execute Good Documentation Practice (GDP) procedure while adhering to all company quality standards and requirements
  • Process Document Change Orders (DCOs) and assess their completeness
  • Distribute controlled copies to the intended locations and retrieve obsolete controlled documents
  • Update and maintain the document master list

 

Manage document control activities and quality records maintenance for the entire company

  • Maintain the master file, obsolete controlled documents, and quality records Act as QS Department’s quality records administrator
  • Collect and maintain QS quality records throughout their archival period
  • Check, segregate and schedule quality records for disposal

 

Training

  • Prepare training requirements for newly hired employees
  • Present Quality System training sessions and coordinate other initial training needs
  • Coordinate with the department heads to ensure employee training files are maintained and current
  • Maintain the training matrix on a regular basis as well as the training files for temporary and or external employees, visitors, consultants as needed
  • Training verification, compliance through follow-up checks and ongoing training to reemphasize system requirements and effectiveness of training

 

Other functions

  • Prepare Document and Quality Records Report for quality management
  • Perform Internal Quality Audit functions as per the Internal Quality Audit Schedule
  • Prepare for and assist with second party and third-party audits and follow-up actions
  • Assist other departments with their DCOs, quality records and other related projects
  • Assist the CAPA Manager, Quality Systems Manager and the Vice-President and Chief Quality Officer as required
  • Other related duties as required

 

Qualifications

Education:

  • Minimum 2 years of post-secondary education in a related discipline or equivalent combination of education and experience
  • Formal auditing training

Experience:

  • Experience establishing compliance with ISO regulations
  • Previous experience working with, and improving, company procedures/SOP
  • Experience auditing company operations compliant to ISO13485 (or similar) within a manufacturing/medical environment

 

Skills:

  • Knowledge of current medical device regulatory requirements (Health Canada, EU CE Mark, and FDA)
  • Knowledge of medical device QS standards (ISO 13485)
  • Working knowledge of Microsoft Office applications such as Excel, Power point, Visio, Word, Access, etc.
  • Strong analytical and problem-solving skills Use of initiative, self-motivation, planning and organizational skills
  • Ability to work with minimal supervision Ability to multi-task and retain flexibility in a dynamic environment

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Company info
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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