Insulet Corporation

  • Quality Technician Team Lead

    Job Locations US-MA-Acton | US-MA-Acton
    Posted Date 1 month ago(1 month ago)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    Our highly automated manufacturing facility in Acton will showcase talented professionals, world-class technologies and innovative solutions that “power” the quality and performance of Insulet Corporation’s unique drug delivery devices. 

     

    The Acton, MA site will become the global business and product development site with all commercial and business functions co-located with all technical disciplines.  This offers a broad range of career and experience building opportunities. Our work is exciting, innovative, and meaningful and all who join have the ability to make an impact – both professionally and personally.

     

    Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes.  Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. 

     

    Insulet is one of the top 5 fastest growing medical device companies in Massachusetts and is ranked #4 on Forbes Most Innovative Growth Companies List. 

     


     

     

    The Quality Technician Team Lead will be a critical contributor in a mission that truly represents an once-in-a-lifetime opportunity to join a company that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people.

     

    The successful candidate will be responsible for ensuring our manufacturing site produces and distributes products which meet or exceed all established quality standards and will be responsible for ensuring our processes and procedures are compliant with corporate policies and federal law. The individual will be cross trained in all operations quality functions including executing incoming inspection on raw materials, performing in-process visual and measurement inspections from the cleanroom, and assessing the final product’s efficacy prior to market release. In addition to those activities, this position may also be required to support production operations, metrology, microbiology, or other manufacturing functions as business needs arise. This position requires a strong attention to detail, problem solving skills, and willingness to work in a fast-paced manufacturing environment.

    Responsibilities

    • Lead and oversee the Quality labs activities (incoming, in process, and finished goods release).
    • Provide training to Quality Technicians
    • Participates in continuous improvement activities and Lean initiatives
    • Required to perform laboratory activities within a cleanroom setting. Inspect and record results of raw materials, work in progress, and finished goods at various stages of the production process to determine and maintain the quality and reliability of our product.
    • Plan and direct the work activities for quality technicians
    • Assist in development and modification of quality control procedures
    • Interact with production supervisors to determine and resolve quality related problems. Work in groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions.
    • Perform normal supervisory functions for a department
    • Assess and complete inspection reports and records including the entry of data into various electronic systems. (For example – Excel, WinSPC, Electronic DHR systems, Oracle Agile, and others)
    • Generate, review, and maintain quality records in support of the Quality System. (For example – device history records, non-conformance reports, corrective and preventative actions, internal audits, and training records)
    • Review and track lot acceptance records and failure trends.
    • Ensure the calibration status of all measuring and critical manufacturing equipment.
    • Perform calibration of instrumentation and equipment which supports the manufacture and testing of product
    • Assist the Quality Manager in notified body and regulatory authority audits and inspections.
    • Works from specifications, work plans, procedures, and general instructions from either Quality Engineers or the Quality Manager.
    • Perform internal audits as required.
    • Required to maintain and enforce cGMPs within the manufacturing operations.
    • Safely follow standard operating procedures including but not limited to quality standards, material handling, and record keeping. Must follow all Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs).
    • Notifies Quality or Operations Leadership of any discrepancies to ensure quality standards and safety of operations are maintained at all times.
    • Maintain a clean work environment suitable for medical device manufacturing and cleanroom production.
    • Performs other duties as required

    Education and Experience

    Minimum Requirements:

    • High School diploma
    • Minimum of 2 year in a Quality related function working within a regulated environment.

     Preferred Skills and Competencies:

    • Proficient in using, reading and interpreting the following: Geometric Tolerancing, Micrometer, Vernier Caliper, Optical Comparator, Microscope, Thread Gauges, Drawings/Prints
    • Excels at generating and maintaining organized and accurate records.
    • Basic computer skills are required. Proficient use of MS Office products (Excel, Word at a minimum) is a plus.
    • Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment.
    • Must be proficient in English language to be able to read documentation, communicate, and write.
    • Ideal candidate will have keen eye for quality, is dependable, and will work collaboratively within a team, and possess a positive attitude. The candidate will have an uncompromising adherence to quality standards.
    • Experience in 21 CFR 820 (QSR) and ISO 13485 regulations.
    • Familiarity with measurement instrumentation such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products.
    • Ability to read and understand engineering drawings for machined parts.
    • Experience with discreet assembly.
    • Experience working in a clean room environment in the medical device industry.
    • Experience in a start-up production environment.
    • Core Competencies:
    • Production & Processing – Knowledge of raw materials, measurement instruments, production processes, quality control, and other techniques for the manufacture and distribution of goods.
    • Mathematics – Basic mathematics skills (adding, subtracting, multiplying, dividing)
    • Problem Solving – Recognizes problems and understands root cause analysis techniques/concepts.
    • Detail Oriented – Excellent attention to detail and good organization
    • Autonomy - Capable of working independently with minimal instruction from their supervisor.

     Physical Requirements:    

    • Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift.
    • Required to reach above shoulder frequently and below waist occasionally.
    • Required to push and pull.
    • Ability to lift up to 20lbs occasionally, 5-20lbs frequently.
    • International travel may be required up to 50% of time during the first 3-6 months of factory acceptance testing of equipment at vendor’s location.

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed