Quality Operations Technician (Weeknight Shift - Onsite)

Job Summary

Join a growing medical device manufacturer where you’ll play a key role in ensuring life-changing products meet the highest quality and regulatory standards. In this hands-on position, you'll perform inspections of raw materials, in-process products, and finished devices, maintain quality documentation, and support compliance with GMP and FDA-regulated manufacturing requirements.

 Job Description

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:

Minimum Requirements:

High School diploma

Minimum of 1 year in a related Quality function or equivalent.

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)

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite

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

Application Details:
This job posting will remain open until the position is filled.
To apply, please visit the Insulet Careers site and submit your application online.

Actual pay depends on skills, experience, and education.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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