John Shevlin Email Address

Director

MidMark Corporation is a medical devices store which offers diagnostic products, dental operatories, dental cabinetry etc.

John is employed at Midmark Corporation as the Vice President of Quality & Regulatory and Technical Service reporting to the COO. He has a strong track record of achieving sustainable results, offering innovative solutions to complex problems and seamlessly crossing organizational boundaries to work in a collaborative environment. He is a results-oriented executive, having a high degree of personal accountability, he also specializes in identifying talent and developing high performing teams. John possesses a diverse, hands-on background in Operations Excellence - Lean, Six Sigma (Green Belt, Black Belt, Green Belt Instructor, DMAIC, DMADV/DFSS) and Lean Sigma in transactional, operational and design projects. Training/Certifications: - AAMI - 21 CFR 820 Quality System Regulation - AAMI - 21 CFR 820.50 Purchasing Controls - AAMI - 21 CFR 820.70 Production and Process Controls - AAMI - 21 CFR 820.75 Process Validation - RAPS - Regulatory Affairs Certificate for Medical Devices - RAPS - Role of the Regulatory Professional - RAPS - Ethics - RAPS - Introduction to Regulatory Affairs in the US and Canada - RAPS - Medical Devices – Definition and Lifecycle - RAPS - Risk Management - RAPS - Canadian Regulations - RAPS - Global Regulatory Strategy for Medical Devices - RAPS - Advertising and Promotion in the US - RAPS - FDA Law and Regulations - Six Sigma Black Belt Certified - Lean Certified - Lean Sigma Certified - Green Belt Trainer Certified Specialties: Manufacturing Operations, Operations Excellence, Quality Assurance, Quality Systems, Risk Mitigation, Reliability, Lean Implementation, Six Sigma, New Production Introduction, Sustaining Engineering, Verification and Validation, Warning Letter Remediation, Consent Decree, Supplier Quality Management, CAPA (Corrective Action, Preventive Action), FMEA, Supplier Development, Global Compliance, IEC 60601, ISO 9000, ISO 9001, ISO 13485, TS 16949, 21 CFR 820, MDD 93/42/EEC, REACH, RoHS.