Insulet Corporation

Manager – Quality Assurance/Quality Engineering Investigation Lab

US-MA-Billerica | US-MA-Billerica
2 months ago
Category
Quality Assurance / Quality Engineering

Position Summary

This position is an integral part of Insulet’s Quality Department. It requires leadership, organization, process knowledge, and attention to detail while working with other Quality functions to ensure compliance and the accomplishment of departmental and company goals. This position is responsible for the management of a complaint lab team (consisting of associate engineers & quality associates) that process all investigations from initiation to closure

Responsibilities

  • Monitor complaint lab activity to ensure timely complaint resolution that meets or exceeds departmental, customer and regulatory requirements.
  • Approve / Sign-off work evaluations from complaint lab team.
  • Technical expert responsible for providing feedback and training concerning write-ups and approvals to drive team improvement.
  • Utilize superior leadership to model, reward, and enforce behaviors that support Insulet’s culture.
  • Supervise, mentor, and provide work direction to the complaint lab team.
  • Drive performance and establish Key Performance Indicators (KPIs) to achieve organizational goals for complaint rate, daily throughput and efficient staff utilization.
  • Works closely with appropriate personnel in Engineering, Operations and Quality Assurance to further analyze investigation results to determine root cause to mitigate and/or eliminate future complaints or customer dissatisfaction.
  • Promote and instill a culture of continuous improvement through standard improvement principles and practices (i.e. line balancing, value stream mapping, pareto analysis, etc.).
  • Establish work planning to include development and maintenance of a plan incorporating hiring, training, efficiencies, etc.
  • Must adhere to all regulatory requirements for complaint handling including the FDA and any other competent authority as required.
  • Purchase appropriate consumables for the continued operation of the complaint Lab.
  • Direct the training efforts on evaluations and procedural changes.
  • Performs other duties as assigned.

 

 

Education and Experience

  • Bachelor’s Degree or equivalent combination of relevant experience in clinical/medical, engineering or a similar scientific discipline.
  • 2-5 years of related experience in medical device complaint processes.
  • 3-5 years of manager / supervisory experience required.
  • Knowledge of Regulatory and Quality Management skills.

 

 

Skills/Competencies:

  • Demonstrated leadership skills and abilities (both of people and process).
  • Effective verbal and excellent technical writing skills.
  • Ability to communicate and work effectively within the organization.
  • Ability to organize and follow through with tasks with minimal supervision.
  • Lead individuals in the process compliance needs of the organization.
  • Excels at generating and maintaining organized and accurate records.
  • MS Office, strong word processing and spreadsheet skills.
  • Familiarity with the handling of biohazardous materials.
  • Demonstrated ability to organize, motivate, empower and build a cohesive team would be a distinct advantage.

 

Physical Requirements:

  • Travel may be required.

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