Design Control Specialist
Insulet Corporation / Neighborhood Diabetes - Bedford, MA

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Job Description:Position overview:
This position works with Program Management, Engineering
and others as the Quality representative on new design
and development projects to ensure new projects meet the
regulatory and quality requirements for medical devices.
Understanding and effectively communicating design and
development regulations, optimizing development, review
and/or approval of design documents and protocols and
ensuring ambiguities and conflicting requirements are
resolved are critical to the success of the position.
JOB / DUTIES / RESPONSIBILITIES
  • Assist design and development teams with realizing new
product development activities incorporating global
regulatory requirements and standards. Collaborate with
design team to develop appropriate Design History File
documents. Review and approve new product documentation
  • Assist in the development of verification and
validation protocols, review and approve protocols.
  • Serve as the Design Control expert on design teams
  • Develop and deliver Design control training for design
teams
  • All other duties as assigned
JOB QUALIFICATIONS
Requirements
Knowledge / Education
  • BS degree, in an engineering/scientific/computer
systems/ or quality management curriculum or equivalent
experience. Masters degree preferred
  • Working knowledge of the Quality System Regulation
(FDA 21 CFR Part 820) and ISO 13485 quality system
standards
  • Working knowledge of Microsoft Office programs (e.g.
Word, Excel, Access, PowerPoint)
Job Experience
  • Minimum of 5 years working with development teams,
specifically in the Medical Device Industry.
  • Experience in the development and implementation of
effective Design Control Systems.
  • Demonstrated experience organizing and maintaining
large documentation sets
  • Ability to follow up with task owners to close out
open items
  • Good written and verbal communication skills
  • Familiarity with structured phase-gate product
development processes
  • Familiarity with FDA, ISO, and other international
regulatory requirements
Skills / Competencies
  • Effective verbal and written communication skills.
  • Experience collaborating and communicate with
individuals at multiple levels in an organization.
  • Ability to organize and judge priorities.
  • Ability to generate and maintain accurate records.
Physical Requirements
  • Ability to lift up to 20 pounds.
Division/Department : Insulet Corporation