Quality Assurance and Regulatory Compliance consulting company specializing in development, maintenance, and audit assessment of quality management systems and regulatory and standard compliance for medical device, biopharmaceutical, and aerospace industries. Particular expertise in assisting start-up and growing companies in achieving scaled solutions to achieving compliance and performance excellence.
Christy Kowalewski, President, is a Quality Assurance and Regulatory Compliance leader leveraging over 20 years of experience in the development/implementation of holistic and compliant quality management systems and innovative solutions to drive compliance, improvement, and efficiency in areas of medical device, biopharmaceutical, and aerospace industries. Proven success in building and maintaining state of the art compliant and efficiently scaled quality system solutions for a wide variety of company sizes and business needs.
SPECIALTIES:
ISO 13485, ISO 9001
21CFR Parts 820, 210, 211
ISO 9001, AS9100, AS9115, DO178, FAA
Software Validation; 21 CFR Part 11
Quality System Audits
Corrective and Preventive Action / Root Cause Investigation
Supplier Management
Product Development Quality Assurance
Technical Files
Risk Management
Medical Device Sterilization
Development and Execution of Quality and Regulatory Training Programs
Process Improvement / Process Mapping
e-QMS Configuration and Validation (MasterControl)
Company Details
- Employees
- 1
- Founded
- -
- Address
- 2201 N Tucson Blvd, Tucson,arizona 85716,united States
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Keywords
- Quality Management Systems, ISO 13485, 21 CFR Part 820, Software Validation, Regulatory Compliance, Audits, Product Development QA, Medical Device Sterilization, electronic QMS system software, MasterControl, 21 CFR Part 210 and 211, ISO 9001, Corrective and Preventive Action (CAPA), Root Cause Investigation, Start-ups, AS9100, Quality and Assurance Training, Technical Files, Improvement, Scaled QMS, Process Mapping.
- HQ
- Tucson, Arizona
- Competitors
- CLK Consultancy, Hfta Careers, CLK Systems, CLK CONSULTING, clk.
Clk Consulting, L.l.c. Questions
Clk Consulting, L.L.C.'s LinkedIn profile is https://www.linkedin.com/company/clk-consulting-l-l-c
Clk Consulting, L.L.C. has
1 employees.
View email and phone details for 1
employees at Clk Consulting, L.L.C..
Clk Consulting, L.L.C.'s industry is
Business Consulting and Services
Clk Consulting, L.L.C.'s top competitors are
Clk Consultancy,
Hfta Careers,
Clk Systems,
Clk Consulting,
Clk.
Clk Consulting, L.L.C.'s categories are Business Consulting and Services
Clk Consulting, L.L.C.'s founding year is 2018
