Quality Operations Technician (Weekday Shift - Onsite)

Insulet Corporation; United States; On-site; USD 26,000 - 40,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Wellness programs

Job summary

Insulet Corporation is seeking an Operations Quality Technician I in the United States. In this hands-on role, you'll perform inspections across incoming materials, in-process production, and final product release to ensure compliance with rigorous quality and regulatory standards within a cleanroom environment.

You will use advanced measurement tools, contribute to continuous improvement, and support audits and regulatory activities.

Qualifications

• High School diploma.
• Experience working in a lab setting in the medical device industry.
• Must be proficient in English reading, writing and communication.

Responsibilities

• Inspect incoming raw materials, in-process materials, and final product at various stages for quality.
• Record inspection results and enter data into ERP/QA systems (e.g., SAP, DHR, Oracle Agile).
• Generate and maintain quality records to support the Quality System.
• Ensure calibration status of equipment is within the specified timeframe.
• Assist in audits and regulatory inspections with the Quality Manager.
• Follow specifications, work plans, procedures, and SOPs from Quality.
• Maintain compliance with cGMPs, GDPs, GLPs, and GMPs.
• Notify leadership of discrepancies to maintain safety and quality.
• Maintain a clean, compliant cleanroom work environment.
• Operate measurement instruments: micrometers, calipers, tensile testers, optical gauges, etc.
• Work autonomously with minimal supervision.

Skills

English proficiency

Lab experience

Basic Math

Autonomy

Measurement tools

Microscopes

Education

High School diploma

Tools

Micrometers

Calipers

Tensile testers

Video microscopes

Optical gauging products

Job description

Job Summary

Join a fast-growing, innovation-driven organization as an Operations Quality Technician I, where you'll play a key role in ensuring high-quality medical device manufacturing. In this hands-on role, you'll perform inspections across incoming materials, in-process production, and final product release to ensure compliance with rigorous quality and regulatory standards. You'll work in a cleanroom environment, utilize advanced measurement tools, and contribute to continuous improvement in a dynamic, fast-paced setting.

Position Overview: The Operation Quality Technician I will be a critical contributor in a mission that truly represents a 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.

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. (For example - Word, Excel, SAP, Electronic DHR systems, Oracle Agile, and others).
• Generate, review, and maintain quality records in support of the Quality System. (For example - device history records, and training records)
• 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.
• Autonomy - Capable of working independently with minimal instruction from their supervisor
• Use of measurement instrumentation such as micrometers, calipers, tensile testers, and optical gauging products.
• Performs other duties as required

Education and Experience

Preferred Minimum Requirements

• High School diploma

Required Core Competencies

• Must be proficient in English language to be able to read documentation, communicate, and write.
• Experience working in a lab setting environment in the medical device industry.
• Mathematics - Basic mathematics skills (adding, subtracting, multiplying, dividing)
• Autonomy - Capable of working independently with minimal instruction from their supervisor.
• Experience working with measurement instrumentation such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products.
• The ability to use stereoscopes and varying microscope setups.

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 (Corrective lenses allowed)

Compensation & Benefits

For U.S.-based positions only, the annual base salary range for this role is $19.23 - $28.85

This position may also be eligible for incentive compensation.

We offer a comprehensive benefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite