Insulet Corporation

  • Post Market Investigation Lab Team Lead

    Job Locations US-MA-Billerica | US-MA-Billerica
    Posted Date 1 month ago(9/7/2018 8:23 AM)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    The Post Market Investigation Lab Team Lead plays an integral part of Insulet’s Quality Department as a hands-on technical leader conducting post market investigations of FDA approved medical devices. The role requires strong organization skills, attention to detail while working in cross functional teams to accomplish of departmental and company goals.

    Responsibilities

    • Provide work leadership to team members, including but not limited to, training support on processes and procedures.
    • Performs complex tasks to ensure compliance with quality standards.
    • Works with quality assurance engineers and other team members to ensure effective inspection, protocols, and procedures are implemented and maintained.
    • Assists in the development of protocols and standards to meet quality specifications and recommends procedural changes.
    • Perform product evaluation including root cause/troubleshooting and failure analysis.
    • Review applicable DHR’s, NCR’s, CAPA’s, and deviations associated with individual complaints.
    • Summarize investigations with Root Cause Analysis and drive further action when appropriate.
    • Approve / Sign-off work of QA Engineers and Associates.
    • Gather, evaluate and trend product reliability data.
    • Assist the Reliability Engineering staff on special projects.
    • Performs other duties as assigned.

    Education and Experience


    Minimum Requirements:

    • BS degree in business, engineering, or scientific discipline.

    Preferred Skills and Competencies: 

    • 5 years of combined education and experience as a lead in engineering, technical or scientific discipline.
    • Preferred 2 years in a Quality related function working with QSR and/or ISO 13485.
    • Electrical and mechanical background strongly preferred. 
    • Effective verbal communication and excellent technical writing skills.
    • Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision.
    • Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred.
    • Experience creating and analyzing charts and Pareto charts in MS Excel a plus.
    • Experience or certification in Lean Six Sigma, SPC, ASQ, and/or ISO process controls a plus.
    • Excels at generating and maintaining organized and accurate records.
    • Complaint management software skills a plus. (i.e. Salesforce, Master Control, PLM etc.)
    • Prior team leadership experience strongly preferred.

    Physical Requirements: 

    • Sitting 70%, Standing 30%
    • Frequent lifting <5lbs
    • Occasional (<5% of time) handling (push/pull) up to 50lbs
    • Ability to operate basic hand tools

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