Insulet Corporation

Quality Manager

US-MA-Acton | US-MA-Acton
2 months ago(10/6/2017 11:50 AM)
Category
Manufacturing Engineering / Supply Chain / Operations

Position Summary

Manages manufacturing plant quality programs, processes, activities, and responsibilities supporting current operations and new product introductions. Manages quality control personnel in the execution of their quality related duties. Interacts with other manufacturing departments (production, maintenance, engineering etc.) as well as with HQ support personnel, suppliers and other external parties on issues related to quality.

 

This role will start in our Billerica MA office and move to Acton when the plant opens.

Responsibilities

 

  • Establish and maintain a manufacturing Quality Management System and team that contributes to outstanding customer service and promotes the highest standards for product quality.
  • Develop and/or manage quality programs and training, complete with tools and processes that support an operational excellence environment and ensure compliance with all company and Federal audit requirements.
  • Establish key quality KPI’s and score carding/tracking mechanisms to ensure continuous improvement.
  • Lead and execute root cause analysis to determine failure causes and implement failure reduction and elimination strategies.
  • Manage existing and create new, if necessary, quality gates to ensure IQA, Pod and sub assembly manufacturing are in compliance and control.
  • Manage existing Lot Qualification process and procedures to ensure Pod and sub assembly manufacturing is in compliance and control.
  • Ensure plant policies and procedures are in compliance with all FDA regulations.
  • Engage with suppliers and supplier development group in monitoring supplier quality performance.
  • Ensure incoming parts/materials are within specification and all required documents are complete and accurate.
  • Ensure suppliers are performing tolerance/specification testing, utilizing Insulet’s prescribed test methods, procedures and equipment.
  • Suggest methods for improving product quality, design, or manufacturing processes.
  • Serve as a team member and leader to provide quality expertise to other manufacturing functional teams.
  • Work cross functionally with HQ and field personnel to promote understanding and cooperation for the quality agenda.
  • Lead all quality and regulatory inspections and audits, as well as the completion of all action items in a timely manner.
  • Maintain all internal and external quality documents and prepare required reports in a timely manner.
  • Identify QC test procedures and equipment required to maintain high product quality.
  • Develop and implement training programs and best practices required to maintain high quality standards.
  • Performs other duties as assigned.

 

 

 

Education and Experience

 

  • BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.
  • 5-10 years’ experience in the FDA regulated environment.
  • Experience in Quality in an FDA regulated industry.
  • Have knowledge, experience and understanding of the tenets of Six Sigma Process and other statistical analysis tools (SPC) required to maintain high standards. Six Sigma black belt preferred.
  • Have knowledge and understanding of ISO programs.
  • High proficiency with software that is centered on process management and statistical data analysis.
  • Successful experience in factory level quality, production and / or maintenance management.  

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 Quality principles using statistics and SPC tools.
  • PC skill, word processing, spreadsheet, database.
  • Able to work effectively in a high-stress, high-energy environment.
  • Able to make effective decisions quickly based on vague or imperfect information.
  • Great interpersonal skills.
  • Track record of leading positive change.

 

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