Careers

     

QA Supervisor

 

Position overview:

The Quality Assurance Supervisor is responsible for all aspects of Document Control and Quality System documentation at Insulet Corporation. The Supervisor manages and supervises other Document Control and Quality Assurance personnel. Responsibilities also include the measurement and reporting of Quality System performance, as well as administration of key Quality Systems. The position is engaged in improvement projects, ensuring efficient and compliant quality systems, and interfaces with all aspects of the business.

 

JOB / DUTIES / RESPONSIBILITIES

  • Supervise Quality System department, which includes but is not limited to the following systems: Training; NCR; CAPA; Deviation: Lot Release, and Document Control systems.
  • Supervise Quality System and Document Control personnel.
  • Oversee Engineering Change Order (ECO) process, ensuring accurate and timely document issuance. Create and update documentation master files.
  • Oversee Device History Record (DHR) Review and Lot Release process, ensuring that DHR documentation is complete and accurate.
  • Control the flow of documents to support manufacturing and product development, as required.
  • Manage Quality System logs and database tracking systems.
  • Generate periodic measurement reports for Quality System performance (e.g. CAPA, Audits, NCR's, Deviations, Training, etc.)
  • Lead or participate as the QA representative in Quality System improvement projects.
  • Perform Internal Audits, and support 3rd Party audit activities.
  • Maintain quality records in compliance with FDA QSR and ISO 13485 standards.
  • Other duties as assigned.

JOB QUALIFICATIONS

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 inspections.
  • Working knowledge of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).
  • Working knowledge of documentation functions in a regulated / medical device industry.
  • Experience supervising diverse teams.
  • Experience leading improvement projects.

Job Experience

  • A minimum of 8 years work experience in a medical device company.
  • A minimum of 5 years of Document Control/Quality System experience or related discipline..

Skills / Competencies

  • Effective verbal and written communication skills.
  • Ability to communicate at multiple levels of an organization.
  • Ability to generate and maintain organized and accurate records.
  • Ability to organize tasks and judge priorities.
  • Skilled in computer use.

Qualified applicants please submit resumes to: careers@insulet.com