Quality Assurance Representative – Commissioning, Qualification & Commercialization (CQC-Q)

Eli Lilly and Company • Indianapolis, IN

1d • $65,250 - $169,400 • Hybrid

About The Position

Quality Assurance professional with 5–7+ years of experience supporting medical device and combination product manufacturing, technical transfer, and contract manufacturer (CM) oversight. Demonstrated ability to ensure process design, validation, and manufacturing readiness meet regulatory and quality requirements.

Requirements

• Bachelor’s degree (or equivalent experience) in a technical/scientific discipline.
• Minimum 5–7+ years of relevant industry experience in Quality, Technical Services, Product Development, or Manufacturing of medical devices.
• Strong knowledge of Quality Systems, validation/qualification, and manufacturing processes.
• Working knowledge of global regulations and standards, including: FDA: 21 CFR Parts 4, 11, 210/211, 820 ISO 13485, ISO 14971 EU MDR, Canadian MDR, JPAL, TGA, ANVISA
• Experience working with contract manufacturers and suppliers.
• Demonstrated ability to influence cross-functional teams and external partners.
• Strong written and verbal communication skills.
• Basic knowledge of statistics and risk management.
• Ability to investigate, analyze, and drive resolution of complex quality issues.

Nice To Haves

• Strong attention to detail, problem-solving, and decision-making skills.
• Audit experience with medical devices and GMP.
• Experience with Kneat, Agile, TrackWise, and Microsoft Office tools.
• Demonstrated technical writing capabilities.
• Ability to explain validation and quality concepts to non-technical stakeholders.
• Experience leading manufacturing readiness assessments and driving improvements.
• Strong organizational, time management, and self-management skills.
• Ability to mentor peers and contribute to continuous improvement within the CQC domain.

Responsibilities

• Provide QA oversight for manufacturing process design, ensuring risks to product quality are identified, mitigated, and validated.
• Lead and support technical transfer and commercialization of medical devices within the IDM portfolio.
• Assess and approve contract manufacturer (CM) Quality Management Systems (QMS), including procedures, training, and maintenance.
• Participate in design and development reviews to ensure manufacturability and compliance.
• Support process validation/qualification activities (components, subassemblies, final device) and change management initiatives.
• Conduct manufacturing readiness assessments and identify/drive remediation of quality gaps.
• Provide Computer System Validation (CSV) support as CSQA reviewer/approver.
• Participate in pFMEA reviews, internal audits, and regulatory compliance activities.
• Develop and maintain SOPs and work instructions; support continuous improvement initiatives.
• Establish and maintain Quality Agreements with contract manufacturers and suppliers.
• Provide cross-functional QA consulting and act as escalation point for technical quality issues.
• Coach and mentor junior QA team members and influence best practices across the domain.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level