Quality Operations Technician (Weeknight Shift - Onsite)

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

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Paid time off

Wellness programs

Job summary

Insulet Corporation seeks an Operations Quality Technician I to ensure high-quality medical device manufacturing. You will inspect incoming materials, in-process production, and final product release, and maintain rigorous quality and regulatory standards in a cleanroom setting.

The role involves using micrometers, calipers, tensile testers, and optical gauging, with autonomy to work independently and support audits by regulatory bodies. Strong documentation and GMP knowledge are required.

Qualifications

• Must be proficient in reading and writing English documentation.
• Experience working in a medical device or regulated lab setting.
• Familiarity with basic measurement instrumentation.
• Ability to work independently with minimal supervision.

Responsibilities

• Inspect incoming raw materials, in-process materials, and finished products to ensure quality.
• Enter data into electronic systems (Word, Excel, SAP, DHR, Oracle Agile).
• Maintain quality records and device history records.
• Ensure calibration status of equipment is current.

Skills

English proficiency

Lab experience

Measurement tools

Autonomy

Education

High School diploma

Tools

Excel

Word

SAP

Oracle Agile

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.

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