Insulet Corporation

Quality Assurance Manager, Europe

UK-London | UK-London
3 months ago
Category
Quality Assurance / Quality Engineering

Position Summary

Manages Insulet Corporation’s compliance activities, including Internal, 3rd Party and Supplier audits, the administration of Management Review, Deviation, Employee Training, and External Standards processes, and oversight of all Document Control and Lot Release functions.  Interfaces with the corporate QA team and other Insulet entities as well as with suppliers and other external parties on issues related to quality.

Responsibilities

  • Manage department efforts toward achievement of established quality goals.
  • Oversee EU-wide initiatives to establish and maintain compliance to ISO 13485 and related regulations and standards. Host 3rd Party Audits/Inspections.
  • Oversee Internal Audit activities and perform audits. Manage cross-functional audit team, and train auditors.
  • Develop and/or manage quality assurance programs related to Supplier/ Distributor Quality. Maintain Supplier/ Distributor files, and oversee the EU elements of the Approved Supplier List (ASL) changes.
  • Oversee EU Document Control requirements and Lot Release functions.
  • Oversee Nonconformity Control & Reporting (NCR) and Deviation processes.
  • Administer EU Management Review input and resulting action items.
  • Manage employee training files and bi-annual SOP training. Perform Quality System training for new and existing employees.
  • Oversee External Standards, including procurement, status changes, and internal review.
  • Evaluate quality system effectiveness with emphasis on preventive action. Suggest methods for improving product quality, documentation, or quality system processes.
  • Perform Quality System monitoring and analysis activities and publish management reports.
  • Review and approve EU Promotional Labeling.
  • Represent the Quality Assurance department at meetings and on project teams.
  • Performs other duties as required.

Education and Experience

  • BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience.  Master’s degree preferred.
  • A minimum of 10 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
  • A minimum of 5 years’ experience managing Document Control/ Quality System or related disciplines.
  • Experience managing and supervising diverse teams.
  • Experience in the development and implementation of effective Quality Systems.
  • Experience leading improvement projects.
  • 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, and PowerPoint).
  • Working knowledge of documentation functions in a regulated / medical device industry.
  • ASQ Certified Quality Auditor and/ or Certified Quality Manager (or equivalent) preferred.

 Skills/Competencies:

  • Effective verbal and excellent technical writing skills.
  • Ability to communicate at multiple levels of an organization.
  • Ability to organize and judge priorities.
  • Excels at generating and maintaining organized and accurate records.
  • Knowledge of Root Cause Analysis / Problem Solving methods.
  • Skilled in computer use including word processing, spreadsheet, and database applications.
  • Able to work effectively in a high-stress, high-energy environment.
  • Able to make decisions quickly based on vague or imperfect information.

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