Quality Operations Technician (Weekend 12 Hour Day Shift - Onsite)

Insulet Corporation•Acton, MA

20h•$19 - $29•Onsite

About The Position

The Quality Operations Technician I supports medical device manufacturing by inspecting incoming materials, in-process production, and final products to ensure they meet established quality standards and applicable regulatory requirements. The role may also support production operations, metrology, microbiology, or other manufacturing functions as business needs arise. It calls for attention to detail, problem-solving ability, and the capacity to work independently in a fast-paced manufacturing environment. The position is performed onsite in a cleanroom and manufacturing environment. The technician uses measurement instruments and microscopes, maintains quality records, checks equipment calibration status, and follows applicable quality systems, procedures, and good-practice requirements. The work schedule is Friday through Sunday, 6:00 a.m. to 6:30 p.m.

Requirements

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% and walk for at least 50% of each shift; frequently reach above shoulder level; occasionally reach below waist; push and pull; and lift up to 20 pounds occasionally and 5–20 pounds frequently.
Vision sufficient to inspect small parts, components, and labeling; corrective lenses are allowed.

Nice To Haves

High school diploma (listed as a preferred minimum requirement).

Responsibilities

Inspect incoming raw materials, in-process work, or lot qualifications at production and distribution stages, and record results to assess product quality and reliability.
Complete inspection reports and records, including entering data into electronic systems such as Word, Excel, SAP, electronic DHR systems, and Oracle Agile.
Generate, review, and maintain quality-system records, including device history records 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.
Work from specifications, work plans, procedures, and general instructions from Quality Engineers, the Quality Supervisor, or the Quality Manager.
Maintain and enforce cGMPs and follow applicable 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 work environment suitable for medical device manufacturing and cleanroom production.
Work independently with minimal supervisor instruction.
Use measurement instruments such as micrometers, calipers, tensile testers, and optical gauging products.
Perform other duties as required.