Quality Assurance Representative – Commissioning, Qualification & Commercialization (CQC-Q)
$65,250–$169,400 year
On-site · Indianapolis, Indiana, United States
Job Summary
Quality Assurance Representative responsible for QA oversight of manufacturing process design, ensuring risks to product quality are identified, mitigated, and validated; leading and supporting technical transfer and commercialization of medical devices; assessing CM QMS; participating in design/development reviews; supporting process validation/qualification and change management; conducting manufacturing readiness assessments and remediation; providing CSV support as CSQA reviewer/approver; participating in pFMEA, audits, and regulatory activities; developing SOPs/work instructions; establishing Quality Agreements with CM/suppliers; providing cross-functional QA consulting; mentoring junior QA staff and driving best practices in the CQC domain.
Required Qualifications
- Bachelor’s degree (or equivalent) 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 (FDA 21 CFR Parts 4,11,210/211, 820; ISO 13485; ISO 14971; EU MDR; Canadian MDR; JPAL; TGA; ANVISA)
- Experience with contract manufacturers and suppliers
- 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
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