

New · posted Nov 8
Insulet · Medical Devices
Quality Operations Technician (Weeknight Shift)
- Massachusetts
- On-site
- Full-time
- Associate & Specialist
The role
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.
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.
What you need
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).
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!
What you'll do
• 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
Pay and benefits
Insulet didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
Employee wellness programs
Incentive compensation eligibility
Where you'll work
MassachusettsOn-siteOpen in Maps (opens in a new tab)
Equal opportunity, accessibility and legal noticesInsulet's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US54 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $46,250 | $48,000 | $51,875 |
Comparisons: the base pay employers published on open Quality Inspection roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Inspection
The general path across 100 open Quality Inspection roles on Regulatory Jobs, with the titles they carry most. Not Insulet's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs8
- GMP and compliance5
- Lab testing and methods5
- Collaboration and leadership4
- Validation and qualification1
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Inspection work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studiesNamed in the posting
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- FDA21 CFR Part 801(official source, opens in a new tab)FDA labeling requirements for medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
Company hiring pulse
Insulet on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 2
- Locations
By discipline
- Quality8 80%
- Regulatory1 10%
- Clinical1 10%
By level
- Associate & Specialist6 60%
- Manager2 20%
- Senior & Principal2 20%
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Quality Operations Technician (Weeknight Shift) at Insulet
Applications close November 14.


