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Lead Document Controller
Lead Document ControlleriMPact Business Group • Kalamazoo, MI, United States
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Lead Document Controller

Lead Document Controller

iMPact Business Group • Kalamazoo, MI, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Job Description

Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Lead Document Controller for a 18 Month + Contract Opportunity . Our client offers results-driven people a place where they can make a difference ? every day! You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in a highly collaborative and professional environment.

Position Description (Principal Duties and Responsibilities)

  • Responsible for all activities related to document routing, distribution and release to assure that the latest effective copies are available as required.
  • Ensure prompt archiving and storage of applicable Stryker documentation.
  • Provides timely retrieval of documents and information, as needed to complete investigations, audits and / or reports.
  • Acts as Subject Matter Expert for document control related activities and processes for the franchise.
  • Develop and provide coaching, training, clinics, support and service to functions in use of and navigation of the PLM system and execution of documentation & change processes.
  • Lead and drive improvement initiatives within the Quality Systems team and participate in multi-functional teams to achieve collaborative results.
  • Act as a single point of contact for process owners during the implementation of external Stryker Documents into local QMS, including the CIDT process.
  • Report on, input to & maintain quality KPI's for Stryker site(s) including periodic review, CIDT process, supplier notifications and Change activity RFT for trending / management reviews.
  • Assist in issue investigations, provide input to correction & resolution, rework, problem solving, and process improvements.
  • Assist with company regulatory audit activities, as deemed necessary.
  • Acts as a backup to the Change Specialist.

Job Requirements

Requirements

  • Bachelor's Degree (preferred).
  • Minimum of 4 years in a Quality / Regulatory Affairs environment with 2 years experience in Document Control or other related function or 0-1 year experience in a Quality / Regulatory Affairs environment.
  • Ability to gain knowledge and understanding of US and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired)
  • Ability to gain knowledge of supporting Quality Systems (e.g. Audits, Management review, Quality Planning).
  • Ability to demonstrate basic communication, identify problems, recognizes areas for improvement and contribute to data management and training
  • Ability to follow instructions, complete task with supervision, identify urgent task and address immediate conflicts
  • Understands basic regulatory concepts, recognizes industry standards and can identifies key regulations.
  • Understands basic communication principles, understands the importance of their input and participates in group discussions.
  • Participates in virtual team meetings and eagerness to understand roles within a team.
  • Provides updates to supervisors, Shares information with team members, Collaborates with peers.
  • Understands data concepts and identifies basic actions from data.
  • High level of PC skills required.
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