Quality Operations Technician (Weekend Day Shift - Onsite)

Insulet Corporation; United States; Sur place; USD 26 000 - 40 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401(k) with company match

Paid time off (PTO)

Wellness programs

Résumé du poste

Insulet Corporation in the United States is seeking an Operations Quality Technician I to support high-quality medical device manufacturing. In this hands-on role, you will perform inspections across incoming materials, in-process production, and final product release to ensure compliance with quality and regulatory standards within a cleanroom environment.

You will use precision measuring tools, maintain quality records, assist audits, and help ensure cGMP/GDP/GLP compliance.

Qualifications

• Requires a High School diploma.
• Experience in a medical device lab environment is preferred.
• Strong attention to detail and problem-solving skills are essential.

Responsabilités

• Inspect incoming raw material, in-process, or lot qualification at various stages of the production process to ensure quality and reliability.
• Assess and complete inspection reports and records in electronic systems (Word, Excel, SAP, DHR, Oracle Agile).
• Generate, review, and maintain quality records to support the Quality System.

Connaissances

Autonomy

Measurement tools

Attention to detail

English proficiency

Regulatory compliance

Formation

High School diploma

Outils

SAP

Oracle Agile

Word

Excel

Electronic DHR systems

Description du poste

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. The successful candidate will be responsible for ensuring our manufacturing site produces and distributes products which meet or exceed all established quality standards and will be responsible for ensuring our processes and procedures are compliant with corporate policies and federal law. The individual will be trained in performing Incoming, In-process inspections in the cleanroom, or assessing the final product's efficacy prior to market release. In addition to those activities, this position may also be required to support production operations, metrology, microbiology, or other manufacturing functions as business needs arise. This position requires a strong attention to detail, problem solving skills, and willingness to work in a fast-paced manufacturing environment.

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)

Additional Information

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.

We offer a comprehensive benefits package, including:

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