Document Control Specialist - Medical Device in Newton, MA

Job Details

  • ID#43837029
  • Address 02458 , Newton,

    Massachusetts

    Newton USA
  • Job type

    Permanent

  • Salary USD $60,000 - $85,000 per year 60000 - 85000 per year
  • Hiring Company

    Jobot

  • Showed05th July 2022
  • Date04th July 20222022-07-04T03:00:00-0400
  • Deadline02nd September 2022
  • Category

    Et cetera

Document Control Specialist - Medical Device in Newton, MA

Vacancy expired!

A leading medical device company that aims to improve cancer surgery is seeking an experienced Document Control Specialist to join the team!This Jobot Job is hosted by: Amber BasingerAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $60,000 - $85,000 per year

A bit about us:A fast-paced start-up that is focused on innovative cancer surgery solutions!

Why join us?Hybrid schedule (onsite 2-3 days per week)100% employer covered health, dental, vision, disability (long & short-term), and life insurance plansComplimentary on-site garage parkingDog-friendly office spaceStay-active space with table tennis, foosball, and video games

Job DetailsResponsibilities:
  • Administrate Arena quality software system and document control process, including acting as a project manager to lead minor change control projects.
  • Coordinate and maintain controlled documentation both physically and electronically according to approved procedures.
  • Assist with file migration to storage, both physically and electronically, as applicable.
  • Coordinate and execute the migration of legacy documentation stored outside of the eQMS into Arena.
  • Ensure all documents are current, properly identified, and maintained per applicable standards and regulations.
  • Aid in investigation and improvement initiatives for quality processes.
  • Review records and documents for completeness and compliance with FDA Quality System Requirements and ISO requirements.
  • Assist in companywide training on general quality principles and specific procedural requirements.
  • Other activities as assigned by supervision including cross-training in other areas of quality and regulatory as applicable.
Core Competencies:
  • Teach and lead others in developing quality skills.
  • Initiate and drive quality system process improvement.
  • Assist, coordinate and participate in quality system audits and regulatory inspections.
  • Conduct process quality measurements/evaluations.
  • Assists in monitoring, analyzing, and reporting trends in key quality metrics.
  • Ensures established department timelines are attained.
Qualifications:
  • Minimum of a bachelor's degree in a life sciences, healthcare, or technology discipline (Preferred).
  • Experience:
o Relevant experience in the medical device industry is required.o Familiarity with FDA medical device regulations and ISO 13485 is required.o Experience in QA document control process administration required.o Experience with effective project management preferred.o Minimum of 3 years of Document Control experience working in an eQMS (Preferably Arena)
  • Knowledge & Skills:
o Ability to read and interpret general technical/quality procedures and quality system regulations.o Ability to write and create medical device manufacturing SOPs and Work Instructions.o Ability to create reports, business correspondence, and procedure manualso Ability to effectively present information and respond to questions verbally, in writing, and in group presentationso Must be skilled in Microsoft Word, Excel, Outlook and Power PointInterested in hearing more? Easy Apply now by clicking the "Apply Now" button.

Vacancy expired!

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