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.
JOB / DUTIES / RESPONSIBILITIES (Listed in order of
administrator, manage workflows, and perform related
- Maintain Quality System processes as system
tasks (e.g. CAPA effectiveness checks).
ensure timely completion and documentation of actions
- Work collaboratively with other functional groups to
taken related to meeting Quality System requirements.
activities and publish management reports.
- Perform Quality System monitoring and analysis
Quality System improvement projects.
- Lead or participate as the QA representative in
System design and implementation.
- Participate in computer based Quality Management
- Perform Internal Audits, and support 3rd Party audit
Files, Approved Supplier List, External Standards,
- Maintain quality records, and logs (e.g. Supplier
External Standard Log, Audit Records, etc.), in
compliance with FDA QSR and ISO 13485 standards.
- Other duties as assigned.
Knowledge / Education
systems/ or quality management curriculum or equivalent
- AS degree, in an engineering/scientific/computer
experience. Bachelors degree preferred.
(FDA 21 CFR Part 820) ISO 13485 quality system standards.
- Working knowledge of the Quality System Regulation
Experience with FDA and ISO 13485 Certification
Word, Excel, Access, PowerPoint).
- Working knowledge of Microsoft Office programs (e.g.
- Experience leading improvement projects.
industry, preferably medical devices.
- A minimum of 5 years work experience in a regulated
Regulatory Affairs role.
- A minimum of 3 years in a Quality Assurance or
Skills / Competencies
- Effective verbal and written communication skills.
- Ability to communicate at multiple levels of an
- Ability to generate and maintain organized and
Division/Department : Insulet Corporation
- Ability to organize tasks and judge priorities.
- Skilled in computer use.
Insulet Corporation / Neighborhood Diabetes - 14 months ago