Manufacturing Quality Assurance Specialist

1 month ago


Anoka, Minnesota, United States Insulet Corporation Full time
Job Description

Insulet Corporation is seeking a highly motivated and detail-oriented Manufacturing Quality Technician to join our team. As a key member of our operations team, you will play a critical role in ensuring the quality and reliability of our products.

Responsibilities:
  • Inspect and record results of work on Incoming raw material, In-process, or Lot Qualification at various stages of the production process, distribution process to determine and maintain the quality and reliability of our product.
  • Assess and complete inspection reports and records including the entry of data into various electronic systems.
  • Generate, review, and maintain quality records in support of the Quality System.
  • Ensure the equipment calibration status is within the timeframe of use.
  • 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, Quality Supervisor, or the Quality Manager.
  • Required to maintain and enforce cGMPs.
  • 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.
Requirements:
  • High School diploma
  • Excellent organizational and record-keeping skills
  • Ability to work independently with minimal instruction
  • Proficiency in English language
  • Basic mathematics skills
  • Familiarity with measurement instrumentation
  • Experience working in a lab setting environment in the medical device industry
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.
  • Vision capability to inspect small parts/components/labeling.

Insulet Corporation is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary range of $17.16 - $25.82 and a comprehensive benefits package.



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