Consulting Opportunities

Noblitt & Rueland provides specialized consulting services for our clients. Periodically, we are in need of additional high quality consulting resources to handle demand or perform specialized tasks. Noblitt & Rueland demands only the highest quality consultants that have a great deal of practical experience in the services they offer. If your background and experience match our requirements please forward your resume* to us by fax at (714) 258-3990, e-mail, or mail.
 

*All correspondence will be kept confidential.

Areas/Experience/Items of Interest:

• Quality System Implementation (FDA QSR/GMP, ISO 13485/9001)
• Auditing (FDA QSR/GMP, ISO 13485/9001)
• Regulatory Affairs-Medical Device & Pharmaceutical Industry
• Writing Submissions- 510k, PMA, IDEs, CE Mark
• Compliance- Inspections, FDA-483s, Warning Letters
• Design Control
• Risk Management/hazard analysis
• Software Development (describe languages and platforms, embedded processors & PCs)
• Software Quality Assurance
• Software Verification & Validation
• Hardware Design (digital & analog)
• Electronic Records (Part 11)/Signature/Documentation Systems
• Proficiency in writing lifecycle procedures (SOPs)
• Proficiency in writing requirements
• Medical Device & Pharmaceutical Industry experience

We are in search of an individuals that are fluent in both the FDA regulations such as; GMP/QSR and a foreign language(s)..