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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in supplier quality management, including supplier qualification, monitoring, and audits, while ensuring compliance with GMP and quality system principles. Proficient in conducting root cause investigations and implementing corrective actions in the medical device and pharmaceutical industries.
Highest-signal resume keywords
Supplier QualificationGMP Manufacturing SupportQuality AgreementsRoot Cause InvestigationSupplier Audits
ATS Keywords
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Hard Skills
Supplier MonitoringNon-Conformance ManagementCorrective Action Plans (CAPA)Quality Documentation ReviewEnvironmental MonitoringMicrobial SamplingSOP ReviewQuality System PrinciplesISO 13485FDA QMSR/21 CFR Part 820
Soft Skills
Cross-Functional CoordinationEffective Communication
Certifications & Qualifications
CMQCQECQAASQ CertificationSix Sigma Certification
Industry Keywords
Medical DevicePharmaceuticalBiotechnologyQuality EngineeringGMP
About the role
Key responsibilities & impact- Support supplier qualification, monitoring, documentation review, quality agreements, and supplier change notifications.
- Assist with supplier-related non-conformances and SCARs, including follow-up of investigations, corrective actions, closure, and effectiveness evidence.
- Support supplier audit activities, including preparation, documentation of findings, supplier response follow-up, and action tracking.
- Assist with component and supplier qualification activities, including documentation collection, quality review, and cross-functional coordination.
- Provide QA support for GMP manufacturing activities, including production quality events, deviations, NCMRs, and quality documentation review.
- Support cleanroom quality activities, including environmental monitoring follow-up, contamination control, excursions, microbial sampling, and related documentation.
- Review SOPs, protocols, reports, GMP records, ECOs, supplier documents, deviations, and validation-related documents under guidance.
- Support continuous improvement activities related to supplier management, investigations, documentation practices, and cleanroom/production quality processes.
- Support internal, customer, regulatory, and supplier audits by preparing objective evidence and tracking audit-related actions.
Requirements
What you’ll need- BSc in Life Sciences, Biotechnology, Biomedical Engineering, Quality Engineering, Industrial Engineering, or similar – must.
- CMQ / CQE / CQA / ASQ certification, Six Sigma certification, or relevant quality/auditor certification – advantage.
- 0-2 years of relevant experience in supplier quality, QA operations, quality engineering, production quality support, or GMP manufacturing support in a medical device, pharmaceutical, or biotech environment – must.
- Previous experience in the medical device or pharmaceutical industry – must.
- Strong advantage in experience with supplier qualification, supplier monitoring, supplier audits, quality agreements, supplier change notifications, supplier-related non-conformances, SCARs, and supplier CAPA effectiveness assessment.
- Good understanding of GMP and quality system principles.
- Knowledge of ISO 13485, ISO 9001, FDA QMSR/21 CFR Part 820, and applicable international standards – advantage.
- Ability to conduct effective root cause investigations and critically assess corrective action strategies.
Benefits
Comp & perks- Health insurance
- Professional development
- Flexible work arrangements