Insulet Corporation

Insulet Corporation

Sr Quality Assurance Engineer (Onsite - Acton, MA)

Acton, Massachusetts · Senior

Sponsorship not specified$87k-$131kDetected 12 days ago
Process ImprovementFDA RegulatoryMedical DevicesCommunicationCollaborationProblem Solving

Stay score

odds of building a lasting career here

50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

Personalize to your clock →

Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 6 green-card filings in this occupation, 100% were for a worker who already held the job.

Green-card follow-through: 85%

Of 13 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 497 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

5 transfer filings in the last year, covering 5 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

Community outcomes

No reports yet — be the first to help the next applicant.

About the role

  • The Senior Quality Assurance Engineer is responsible for ensuring quality, compliance, and continuous improvement within the manufacturing of Insulet's Omnipod medical devices.
  • The ideal candidate has 5-7 years of quality engineering experience in a regulated medical device environment, strong knowledge of quality standards and validation methods, and excellent collaboration, communication, and root cause analysis skills.
  • The Senior Quality Assurance Engineer role is responsible for supporting manufacturing line/equipment implementation and validation as well as continuous improvement of existing production processes for Insulet's Omnipod products.

Responsibilities

  • Supports manufacturing process development & qualification for new product commercialization, product changes, and manufacturing capacity expansion efforts.
  • Collaborate with manufacturing sites, globally, to rollout manufacturing / quality / process improvements
  • Ability to generate and maintain organized and accurate records.
  • 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.

Nice to have

  • BS degree in engineering, a technical or scientific discipline
  • Master's degree in engineering or technical or scientific discipline preferred.
  • 5-7 years' experience in the FDA regulated environment.
  • Experience in Quality in an FDA regulated industry.
  • Experience with QSR Part 820, ISO 13485 and ISO 14971.
  • Experience with high-volume manufacturing single-use products.
  • Preferably automated manufacturing equipment
  • Experience with statistical methods (e.g. statistical process control, sampling plans, Test Method Validation, gauge R&R, and capability).

Skills

  • Effective verbal and written communication skills.
  • Effective collaboration and communication with individuals at multiple levels in an organization.
  • Ability to organize and judge priorities.
  • Ability to generate and maintain accurate records.
  • Ability to follow up with task owners to close out open items.
  • Strong problem solving / root cause analysis skills.
  • Good verbal (including presentation) and written communication skills, especially technical report writing.
  • Flexibility in multiple time zones, outside of normal working hours
  • Travel (International) - 5%
  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO)

Compensation

  • Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $87,300.00 - $130,950.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:

Company info

  • We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
Apply directly at Insulet Corporation →Create a free account for alerts like thisView Insulet Corporation immigration profile

This listing is sourced directly from Insulet Corporation's careers page and normalized into a canonical job model.