Prime Medicine
Senior Quality Engineering Specialist
Cambridge, MA · Senior · Full-time
Stay score
odds of building a lasting career here
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 →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$6,291 more — $117,291 — moves this role to Level III and 3 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $117,291 would place this position at wage Level III. That figure is within the posted range, and I'd like to target it. This role classifies under "Software Quality Assurance Analysts and Testers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Software Quality Assurance Analysts and Testers (15-1253) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- Collect and review vendor questionnaires, certifications, audit materials, quality agreements, and other supporting evidence.
- Work with IT/Informatics, system owners, Quality colleagues, and vendors to resolve documentation or performance gaps and complete assigned actions.
- Draft, execute, and review equipment qualification protocols, including IQ/OQ/PQ activities.
Responsibilities
- Support quality oversight of GxP computerized systems, including AI-enabled software tools, in accordance with company procedures and applicable regulatory expectations.
- Conduct and document risk-based assessments of software, equipment, material, and service providers.
- Support the documentation and investigation of equipment qualification discrepancies.
- Maintain equipment, calibration, and preventive maintenance records in the computerized maintenance management system.
- Review and electronically maintain calibration certificates, maintenance records, and service reports, ensuring that documentation is complete and properly linked to the applicable equipment.
- Supplier Quality and Quality Systems Support
Requirements
- Bachelor's degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience.
- Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements.
- Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records.
- Experience using a computerized maintenance management, calibration management, or equipment tracking system.
- Experience in biotechnology, gene therapy, cell therapy, or another regulated life sciences environment.
- Familiarity with equipment lifecycle activities (URS, IQ/OQ/PQ, periodic review, calibration, maintenance) or software assurance/CSV practices.
- Experience supporting supplier qualification, vendor assessments, or laboratory instruments and CMMS records.
- At least four years of experience in a regulated life-sciences environment, including experience in equipment qualification, software assurance/CSV, calibration or maintenance oversight, supplier quality, or a related quality function.
- Ability to manage multiple operational priorities, maintain accurate records, and escalate risks or delays promptly.
- The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).
- Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits-including medical, dental, vision, life insurance, a 401(k) match, and equity programs-along with generous paid time off, wellness days, and company-wide recharge breaks.
- Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.
Nice to have
- Preferred Experience
Skills
- Strong technical writing, organization, and cross-functional coordination skills.
Compensation
- $111,000 - $123,000 USD
Equal opportunity
- Prime Medicine is proud to be an equal opportunity employer.
This listing is sourced directly from Prime Medicine's careers page and normalized into a canonical job model.