Sr. Quality Systems Specialist
Insulet Corporation / Neighborhood Diabetes - Bedford, MA

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Job Description:
Position overview: The Sr. Quality System Specialist is
responsible for performing duties associated with
maintaining effective quality systems and compliance at
Insulet Corporation. Responsibilities include the
administration of key quality systems as well as the
measurement and reporting of Quality System performance.
The position is engaged in improvement projects,
ensuring efficient and compliant quality systems, and
interfaces with all aspects of the business.
  • Maintain Quality System processes as system
administrator, manage workflows, and perform related
tasks (e.g. CAPA effectiveness checks).
  • Work collaboratively with other functional groups to
ensure timely completion and documentation of actions
taken related to meeting Quality System requirements.
  • Perform Quality System monitoring and analysis
activities and publish management reports.
  • Lead or participate as the QA representative in
Quality System improvement projects.
  • Participate in computer based Quality Management
System design and implementation.
  • Perform Internal Audits, and support 3rd Party audit
  • Maintain quality records, and logs (e.g. Supplier
Files, Approved Supplier List, External Standards,
External Standard Log, Audit Records, etc.), in
compliance with FDA QSR and ISO 13485 standards.
  • Other duties as assigned.
Knowledge / Education
  • AS degree, in an engineering/scientific/computer
systems/ or quality management curriculum or equivalent
experience. Bachelors degree preferred.
  • Working knowledge of the Quality System Regulation
(FDA 21 CFR Part 820) ISO 13485 quality system standards.
Experience with FDA and ISO 13485 Certification
  • Working knowledge of Microsoft Office programs (e.g.
Word, Excel, Access, PowerPoint).
  • Experience leading improvement projects.
Job Experience
  • A minimum of 5 years work experience in a regulated
industry, preferably medical devices.
  • A minimum of 3 years in a Quality Assurance or
Regulatory Affairs role.
Skills / Competencies
  • Effective verbal and written communication skills.
  • Ability to communicate at multiple levels of an
  • Ability to generate and maintain organized and
accurate records.
  • Ability to organize tasks and judge priorities.
  • Skilled in computer use.
Division/Department : Insulet Corporation

Insulet Corporation / Neighborhood Diabetes - 2 years ago - save job