Quality Operations Technician - Weeknight Shift

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.