Responsible for ensuring design quality and regulatory compliance throughout the medical-device product development lifecycle, from concept and design through verification, validation, release, and post-market activities. Leads design controls, risk management, quality reviews, CAPA, change control, and verification/validation activities while partnering with Engineering, Regulatory, Manufacturing, and other cross-functional teams to deliver safe, effective, and compliant products. Current medical-device postings emphasize design controls, ISO 13485, ISO 14971, FDA requirements, and V&V.
High school diploma or equivalent. Zero (0) to one (1) year warehouse experience or related experience and/or training.
Obtains and/or maintains appropriate licenses / training / certifications, as needed.
Has basic skills training in an analytical / scientific method or operational process area (e.g., material handling and management, logistics, manufacturing production).
Effective communication skills at a level co-workers and Team Lead/Supervisor can understand.
Ability to read, write, interpret and comprehend documents written in English and perform basic math calculations. Ability to perform/operate in a metrics-driven environment.
General computer skills.
Must be able to work Monday - Thursday, 8pm- 6:30am. Uses a variety of equipment such as forklifts, conveyers, cranes, handcarts, and power trucks to move materials, parts, assemblies and finished products or goods within a plant, office or warehouse.
May maintain records.
Develops skills in basic tasks, techniques and procedures within one skill area / process / method.
Applies basic knowledge and skills to complete routine tasks consisting of prescribed steps.
Works within clearly defined SOPs and / or scientific methods and adheres to quality guidelines.
Works under general to limited supervision.
Numbers & Facts
Location
Covington, KY
Skills
Analysis Skillsunmatched
Change Controlunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Craneunmatched
Cross-Functionalunmatched
Design Verificationunmatched
English Languageunmatched
FDA Requirementsunmatched
Forkliftunmatched
High School Diplomaunmatched
ISO (International Organization for Standardization)unmatched
Logisticsunmatched
Manufacturingunmatched
Manufacturing Requirementsunmatched
Material Movingunmatched
Materials Managementunmatched
Mathematicsunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Metricsunmatched
Operations Processesunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Record Keepingunmatched
Regulatory Complianceunmatched
Risk Managementunmatched
Scientific Methodunmatched
Standard Operating Procedures (SOP)unmatched
Team Lead/Managerunmatched
Validation Testingunmatched
Warehousingunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.