Susan Clairmont

About Susan Clairmont

Professional Experience -Medical Device Manufacturing: Sustaining & Supplier Quality Engineering and Project Management, including sterile implantable Class products and sterile/non-sterile Class II, and Class I products, to support process, design, cleaning and packaging validations, process verifications, risk assessments, commercial labeling, and investigations/CAPAs to ensure regulatory compliance. Support Design Quality through DHF/DHR reviews. Protocol development for capital project, packaging tests, and justifications. Technical research to ensure compliance (Medical Device Directives). Reviewer and team member to complete FMEAs (Process and Design). Authored SOPs for manufacturing equipment and System Improvement. Kaizen team member and leader. Incoming inspection manager. Sterilization (EtO) compliance manager.Pharmaceutical Manufacturing: Quality Product Manager between Product Development team and Client. Product Development Manager and liaison with multi-functional team for Clinical Trial Phase I, II, and initiatives, including protocol, Master Batch Record review, cleaning validation, risk assessment, bulk labeling, change control, and deviation reviews, and providing guidance to ensure regulatory compliance. Author/coordinator of Quality Technical Agreements (QTAs) between company and Client. Reviewer and team member to complete FMEAs. Author/reviewer to update SOPs for system improvement. Internal auditor and support for external audits.Utility Industry: Developed corporate-wide Environmental, Health, and Safety compliance training programs. Expert in EHS regulatory compliance audits, including corrective action remediation. Authored technical, site-specific environmental manuals, & EHS protocols. Program Manager for energy-efficiency demand side management (DSM) program. Mechanical modifications design for nuclear power plant.Career Goals: Searching for a contract position where my quality and manufacturing engineering, project management & team building can be utilized to achieve company goals.Medical Device & Pharmaceutical: Black Belt Certification; Quality; Project Management; Supplier Quality, Sustaining & New Product Design (R&D-Quality); Risk Assessments; Packaging; Protocols; Validation (IQ, OQ, PQ); Author SOPs; CAPA; PFMEA and DFMEA; EU MDR compliance; MDD; Audits (Internal/External); Kaizen/CI. Utility: Project Management, EHS Training & Development, EHS Compliance Audits, Environmental Compliance Manuals, Regulatory Interpretations, DSM Program Development & Implementation, Nuclear Plant Modifications.

Experience

1. Director of Quality Assurance

   Endo-Therapeutics, Inc

   Mar 2024 — Present

Education

• West Virginia University Institute of Technology

  Bachelor of Science

• St. Petersburg College

  Black Belt Certification

Skills

• Manufacturing
• Six Sigma
• Quality System
• V&V
• Continuous Improvement
• Lean Manufacturing
• Kaizen
• Minitab
• Fda
• Program Management
• Quality Assurance
• Engineering
• Gmp
• Process Improvement
• Root Cause Analysis
• Validation
• Manufacturing Engineering
• Testing
• Medical Devices
• Capa
• Iso 13485