Senior Engineer/Scientist – Post-Market Quality (PMQ)
Location: Indianapolis, Indiana, United States
Job Type: Full-Time | Permanent
Category: Quality Assurance
Sub-Category: Diagnostics / Post-Market Quality
Experience Required: 3–5+ Years
Industry: Medical Diagnostics / Life Sciences
Job ID: 202511-129089
Posted Date: 01 December 2025
About Roche
Roche is a global leader in pharmaceuticals and diagnostics, dedicated to improving patient outcomes through innovation and scientific excellence. Our Post-Market Quality (PMQ) teams ensure that our products meet the highest standards of performance, reliability, and safety in the market. By joining Roche, you become part of a collaborative, inclusive environment where your expertise and contributions directly impact patients and healthcare systems worldwide.
Position Overview
We are seeking a Senior Engineer/Scientist – Post-Market Quality (PMQ) to join our CoreLab Network in Indianapolis. This role focuses on mass spectrometry and Cobas i 601 hardware, ensuring superior product quality and compliance with global regulations, ISO standards, and Roche’s internal mQMS.
You will manage complaints and inquiries from the market, including safety-relevant cases, independently and with minimal supervision. This role requires analytical expertise, regulatory knowledge, and a proactive approach to Corrective and Preventive Actions (CAPAs), non-conformities, and continuous process improvement.
Key Responsibilities
Handle customer complaints and inquiries related to mass spectrometry and Cobas i 601 hardware, ensuring accurate documentation and resolution.
Perform acceptance, classification, investigation, and closure of complaints in compliance with applicable ISO standards, GMP, and Roche mQMS.
Collaborate with global and local teams (R&D, Operations, CDMA) to identify corrective actions and communicate quality information to country organizations.
Conduct statistical analysis of product data to identify trends, potential issues, and risk mitigation strategies.
Initiate CAPAs, non-conformities, and implement solutions to ensure product safety, performance, and compliance.
Support knowledge transfer and training for new products, ensuring continuity and system expertise across teams.
Mentor new team members and support onboarding activities.
Contribute to regular quality and performance reporting, documenting post-market product performance.
Required Qualifications
Bachelor’s or Master’s degree in Medical Technology, Electrical Engineering, Biotechnology, Chemistry, or a related field.
3+ years of experience in a technical product support role; 5+ years preferred.
Expertise in mass spectrometry and diagnostic instrumentation.
Knowledge of GMP, ISO standards, and regulatory requirements in diagnostics or related fields.
Strong problem-solving, analytical, and communication skills, with the ability to collaborate across functions.
Business-fluent English (written and spoken) is required.
Ability to work independently and prioritize tasks effectively.
Preferred Qualifications
Experience in post-market quality, technical customer support, or R&D in diagnostics.
Familiarity with risk assessment, CAPA management, and complaint resolution processes.
Demonstrated capability in mentoring and guiding team members.
Location & Travel
On-site position in Indianapolis, Indiana.
Minimal domestic and international travel may be required.
Relocation benefits are not provided for this position.
Compensation & Benefits
Salary range: $62,370 – $135,370 USD (depending on experience, qualifications, and location).
Discretionary annual bonus may be available based on performance.
Comprehensive benefits package including healthcare, retirement, and professional development opportunities.
Why Join Roche
Work in a dynamic, collaborative PMQ team ensuring world-class product quality.
Solve complex diagnostic and technical challenges with impact on global healthcare.
Drive continuous improvement and innovation in post-market product performance.
Be part of a company committed to scientific excellence, inclusion, and patient outcomes.
Roche is an Equal Opportunity Employer. Employment decisions are based on merit, qualifications, and competence, without discrimination. Reasonable accommodations are available for applicants with disabilities.
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