Quality Operations Technician (Weekday Shift - Onsite)

Insulet Corporation•Acton, MA

4d•$19 - $29•Onsite

About The Position

The Quality Operations Technician I helps ensure medical device manufacturing products meet established quality standards and that processes and procedures comply with corporate policies and federal law. The role conducts inspections of incoming materials, in-process production, and final products before market release, and maintains related inspection reports and quality records. Work takes place in a cleanroom and other manufacturing settings, using measurement instruments and electronic systems. Depending on business needs, the technician may also support production operations, metrology, microbiology, or other manufacturing functions. The position calls for attention to detail, problem-solving skills, and the ability to work independently in a fast-paced environment. The technician works from specifications, work plans, procedures, and general instructions provided by Quality Engineers, a Quality Supervisor, or the Quality Manager. The role also supports audits and inspections, maintains calibration and quality records, and follows applicable quality, safety, documentation, and laboratory practices.

Requirements

High school diploma is listed as the preferred minimum education requirement.
Proficiency in English to read documentation, communicate, and write.
Experience working in a laboratory setting in the medical device industry.
Basic mathematics skills, including addition, subtraction, multiplication, and division.
Ability to work independently with minimal instruction from a supervisor.
Experience using measurement instruments such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products.
Ability to use stereoscopes and varying microscope setups.
Ability to stand for at least 75% of the shift and walk for at least 50% of the shift.
Ability to frequently reach above shoulder level and occasionally reach below waist level, and to push and pull.
Ability to lift up to 20 pounds occasionally and 5–20 pounds frequently.
Vision sufficient to inspect small parts, components, and labeling; corrective lenses are allowed.

Responsibilities

Inspect and record incoming raw materials, in-process work, and lot qualifications at production and distribution stages to assess product quality and reliability.
Complete inspection reports and records, including entering data into electronic systems.
Generate, review, and maintain quality-system records, including device history and training records.
Ensure equipment calibration is current when equipment is used.
Assist the Quality Manager with notified body and regulatory authority audits and inspections.
Follow specifications, work plans, procedures, and instructions from Quality Engineers, the Quality Supervisor, or the Quality Manager.
Maintain and enforce current Good Manufacturing Practices (cGMPs), and follow GMP, GDP, GLP, quality, material-handling, and record-keeping procedures.
Notify Quality or Operations Leadership of discrepancies that could affect quality standards or operational safety.
Maintain a clean environment suitable for medical device manufacturing and cleanroom production.
Work independently with minimal supervisor instruction.
Use measurement instruments, including micrometers, calipers, tensile testers, video microscopes, and optical gauging products.
Perform other duties as required.