ALKU is a specialized consulting services firm focused on deploying highly skilled consulting resources in the areas of ERP, HCIT, Life Sciences, and Government Programs.Websitewww.alku.comBlogwww.alku.com/resources/alkummunitySocial Media@LifeAtALKU

Here at ALKU, I focus on the placement of high level, talented experts within the areas of quality and compliance, regulatory affairs, and validation serving Medical Device and Diagnostics companies nationwide. I support my consultant’s long-term career success, providing the challenging opportunities and skills development they need to reach the top of their profession. My number one priority here at ALKU is to build sound relationships with both consultants and clients alike in the hopes that we are not only engaging in business but also a partnership with one another. It is these relationships which allow me to connect individuals to the perfect opportunity that best suits their skills and interests, at the right time.Keywords/Specialties: Quality Compliance, Validation, Regulatory Affairs, Medial Devices, Diagnostics, Quality Engineering, Recruiter, FDA Rules & Regulations, Quality Assurance / Engineering, Recruiter, GMP/GCP/GLP/QS Audits, Quality Systems implementations, process improvement, SOP red-lining/creation, work instruction and procedures development, ISO 13485 implementations/upgrades, Batch Records Review, Complaint Handling, CAPA, Adverse Event, and MDR process improvements and remediation, DMR/DHF Remediation, Mock FDA Audits, MO/Supplier Audits, FDA regulatory submission preparation/review, Regulatory Compliance training, Regulatory Filings, 510(k) Submissions, LE Mark, PMA Submissions, NDA, IDE, IND, Regulatory Strategy, Technical Files, MVP Development, Process and Product Validation Computer Systems Validation (CSV)- (ERP, LIM, QS Software, Training Software, etc.), Equipment Validation, Facilities and Utilities Validation, IQ/OQ/PQ Protocol Development and Execution