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Experienced Quality Assurance Analyst
OneTrustExperienced Analyst in Quality Assurance performing instrument qualification and supporting validation at Johnson & Johnson. Delivering quality assurance in MedTech environment and contributing to continuous improvement efforts.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in instrument qualification, laboratory Lifecycle Management, and Quality Control standards within a cGMP environment. Proficient in troubleshooting, conducting investigations, and supporting validation protocols in the medical devices or life sciences sectors.
Highest-signal resume keywords
Instrument QualificationLaboratory Lifecycle ManagementQuality Control StandardsCGMP EnvironmentTroubleshooting
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Instrument QualificationLaboratory Lifecycle ManagementValidation Protocols ExecutionRoot Cause AnalysisCorrective Action Plans
Soft Skills
Effective DiagnosticsProblem Solving
Industry Keywords
Medical DevicesPharmaceuticalBiotechnologyQuality ManagementLaboratory Procedures
About the role
Key responsibilities & impact- Perform routine and complex instrument qualification in compliance with laboratory procedures to support the lab and manufacturing
- Develop and revise laboratory Lifecycle Management SOPs.
- Support investigations to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.
- Support validation protocols execution.
- Provide hands-on and effective diagnostics/troubleshooting functions
- Provide laboratory support for capital projects concurrently with a dynamic workload based upon site priorities
- Apply functional knowledge of Quality Control standards to review results of quality audits and regulatory inspections, identify quality issues, and provides support corrective action plans
Requirements
What you’ll need- University/bachelor’s degree in Science / Technical discipline.
- Requires 2-4 years of related work experience
- Strong background and knowledge of Laboratory cGMP Environment.
- Prefer experience in medical devices or life science management, quality management or related field (Medical Devices, Pharma, biotechnology, or equivalent).
Benefits
Comp & perks- Inclusive work environment
- Employee health and wellness programs
- Opportunities for professional development