Verista, Inc.
6556-Subject Matter Expert - Combination Products Quality & Compliance Lead GxP Auditor
Portage, MI · Senior
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). 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
$8,512 more — $115,773 — 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 $115,773 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 Developers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Software Developers (15-1252) · Kalamazoo-Portage, MI. 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
- Verista is looking for an experienced Senior Subject Matter Expert (SME) to act as Lead GxP Auditor on a client engagement with Client.
- The SME will design, deliver, and support a custom Lunch and Learn training on combination products for Client process owners.
- The training covers applicable regulatory requirements, quality system expectations, process owner responsibilities, and key compliance considerations.
Responsibilities
- Lead a kickoff meeting with Client stakeholders to understand organizational needs and training objectives.
- Develop a customized Quality & Compliance Lunch and Learn presentation that incorporates key standards and industry best practices.
- Support recording of the session for people who cannot attend.
- Lead a question-and-answer session after the presentation.
- Phase 3 - Post-Training Support (approx. 60 hours)
Requirements
- Bachelor's degree in a life science, engineering, or related technical field.
- Deep working knowledge of combination product regulations and drug and device quality system requirements.
- Able to travel to client sites as required.
- Advanced degree in a relevant discipline.
- Experience supporting inspection readiness and regulatory inspections.
- Consulting experience in client-facing, time-and-material engagements.
- 10+ years of experience in quality assurance, regulatory compliance, or auditing in the pharmaceutical, medical device, or combination product industries.
- Proven experience as a lead GxP auditor, including audit program development and execution.
- Familiarity with global regulatory frameworks (FDA, EMA, MHRA, Health Canada, PMDA, MFDS, TGA, Medsafe).
- Demonstrated experience developing and delivering training to technical and cross-functional audiences.
- Strong presentation, facilitation, and stakeholder communication skills.
- Professional certification such as ASQ CQA, CQE, or RAC.
- The chance to shape quality and compliance practices at a leading medical technology company.
- Flexible, mostly remote work with focused on-site engagement.
Compensation
- For US geography, the salary range for this position is shown below.
- Therefore, in some circumstances, the actual salary could fall outside of this expected range.
- This salary range is subject to change and may be modified in the future.
- $107,261 - $171,339 USD
Benefits
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Tuition Reimbursement
- Paid Parental Leave and Bereavement
Company info
- Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives.
Equal opportunity
- equal opportunity employer.
This listing is sourced directly from Verista, Inc.'s careers page and normalized into a canonical job model.