Quality Operations Technician (Weekend Night Shift - Onsite)

Insulet Corporation; Acton (MA); On-site; USD 26,000 - 40,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off

Job summary

Insulet Corporation in Acton, MA is seeking an Operations Quality Technician I to support quality inspection across incoming materials, in-process production and final release within a cleanroom environment.

You will record data in SAP and other systems, maintain calibration, and assist in audits while following GMPs and GDPs. The role emphasizes independent work and strict adherence to regulatory standards.

Qualifications

• English reading, writing and documentation proficiency.
• Experience working in a lab environment within the medical device industry is preferred.
• Basic math skills including adding, subtracting, multiplying and dividing.
• Ability to work independently with minimal supervision.
• Experience using basic measurement instrumentation and related equipment.

Responsibilities

• Inspect and record results on incoming raw materials, in-process, and final release stages.
• Generate and maintain quality records and enter data into electronic systems (SAP, DHR, Oracle Agile).
• Ensure calibration status of equipment is current and within use timeframe.
• Assist in audits and inspections by QA leadership.
• Follow GMP, GDP, GLP and other regulatory requirements.
• Maintain a clean room and workplace suitable for medical device manufacturing.
• Communicate discrepancies to Quality or Operations leadership as needed.
• Use micrometers, calipers and optical gauging tools for measurements.
• Operate according to standards, work plans and SOPs.

Skills

English proficiency

Lab experience

Mathematics

Autonomy

Measurement tools

Optical gauging equipment

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.

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