Quality Operations Technician (Weeknight Shift - Onsite)

Insulet Corporation•Acton, MA

3d•$19 - $29•Onsite

About The Position

The Quality Operations Technician I supports a medical device manufacturing site by ensuring products and processes meet established quality standards, corporate policies, and applicable federal regulations. The role includes training in incoming and in-process inspections, including cleanroom work, and assessment of finished-product efficacy before market release. Depending on business needs, the technician may also support production operations, metrology, microbiology, or other manufacturing functions. The position requires attention to detail, problem-solving ability, and the capacity to work independently in a fast-paced manufacturing environment. The technician inspects raw materials, in-process products, and lot qualifications; records and evaluates inspection results; and creates and maintains quality-system documentation. The role also includes checking equipment calibration status, supporting audits and inspections, maintaining cGMP and other good-practice requirements, following safety and quality procedures, reporting discrepancies, and keeping the work area suitable for medical-device and cleanroom production. The position is onsite and involves substantial standing and walking, reaching, pushing and pulling, occasional lifting, and visual inspection of small parts and labels.

Requirements

High school diploma.
At least 1 year in a related Quality function or equivalent.
Proficiency in English sufficient 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 with measurement instrumentation 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 each shift and walk for at least 50% of each shift.
Ability to reach above the shoulder frequently and below the waist occasionally, and to push and pull.
Ability to lift up to 20 pounds occasionally and 5–20 pounds frequently.
Vision capability to inspect small parts, components, and labeling; corrective lenses are allowed.

Responsibilities

Inspect and record results for incoming raw materials, in-process products, or lot qualifications at stages of production and distribution.
Assess and complete inspection reports and records, including entering data into electronic systems.
Generate, review, and maintain quality 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, and GLP requirements.
Safely follow standard operating procedures for quality standards, material handling, and record keeping.
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 instrumentation, including micrometers, calipers, tensile testers, and optical gauging products.
Perform other duties as required.