Bob Haldane

Background

About Bob Haldane

19 years total experience in pharmaceutical/medical device/medical instrumentation/aerospace manufacturing environments which included QA Compliance, Technical Support and Validation roles and responsibilities. Trained and experienced in internal and external auditing for 21 CFR 211, 21 CFR 820 and ISO 13485 and AS9100 Rev D compliance. • Most recently, QA Engineer with 11+ years of cGMP experience in medical device CNC machining manufacturing environments which included QA Compliance, Technical Support, Continuous Improvements and Validation roles and responsibilities. Trained and experienced in documentation, regulatory controls, internal and Supplier auditing for cGMP quality management systems for compliance to ISO 13485 and 21 CFR 820. • Diverse history of supporting regulatory compliance including on-site and remote auditing of Suppliers and internal departments, documentation (CAPA, PFEMA, PPAP), investigations, MRB team member, production process trouble shooting, validation of process/equipment/utilities (DQ’s, FAT, SAT & IQ/OQ/PQ's) and execution of Gage R&R studies. Solid understanding of manufacturing statistics including Process Capability calculations (Pp, Ppk, Cp & Cpk), Normality Testing, Transformation of Non-Normal Data Sets, and application of Operating Characteristic Curves to Sample Plans. Trained by Dr. Wayne Taylor on validation principles and statistical calculations. • Degrees include a Bachelor of Science in Chemistry and an Associate of Science in Electronic Technology.