Jonathan Coleman, Cqe, Cssbb Email & Phone Number

Charlotte, North Carolina, Us

Safeguard medical device manufacturing and pharmaceutical virtual manufacturing operations by diminishing risks and ensuring international regulatory compliance.• Champion Quality Management System (QMS) health to bolster operational execution, deliver best-in-class products, and protect clinicians and patients.• Interpret and implement EU MDR, ISO13485:2016, MDSAP, and other regulations to elevate the Quality culture and acquire / sustain applicable certifications.• Oversee International Regulatory submissions and product registrations for medical devices and pharma products.• Monitor and control over a hundred suppliers, subcontractors, and outsourced processes to ensure on-time delivery of medical devices and pharma products meeting specifications.

Gaithersburg, Maryland, Us

Deliver bleeding-edge QA and operational excellence initiatives to advance biotech/pharma manufacturing.• Develop sustainable agile processes and provide comprehensive QA oversight of Facilities & Maintenance, Inspection & Packaging Operations, Manufacturing Operations, QC Laboratories, and Warehouse areas.• Cultivate internal and external partnerships to ensure best-in-class product turnaround, on budget, for 40+ CDMO clients and government agencies.• Identify and eliminate risks to delivery of high quality drug products.• Lead and ensure clear focus for team of 20 QA and operations subject matter experts.• Build programs with global application to improve site-to-site alignment and compliance.

Shelton, Connecticut, Us

Transform vendor quality performance and internal compliance metrics.• Champion quality assurance brand positioning processes to exceed consumer expectations.• Spearhead implementation of PPAP program, designed to ensure devices and processes consistently meet parameters.• Develop organizational process improvement (statistical engineering, Six Sigma, etc.) and regulatory competencies

Shelton, Connecticut, Us

Commanded internal control team to ensure development of and compliance with quality standards that align with the business.• Engineered quality system operation to implement medical device compliance plan.• Initiated investigations for sampling to establish validity and timeliness.• Organized complaint handling unit to fulfill federal regulatory requirements.• Integrated certification transitions with complex quality management systems.• Consulted with team regarding medical device process/risk assessments and validations.

Shelton, Connecticut, Us

Formulated nonconformance and goods reduction plan to yield an average annual savings of $175,000.• Constructed quality system regulation compliant sampling policies.• Qualified suppliers, packagers, and vendors by standardizing site audits.• Advised team regarding corrective and preventive action.• Tested and assimilated manufacturing operations for change control.• Delegated team to ensure consistency, proliferate quality, enhance productivity, and conserve cost.• Produced requirements for packager quality management based on business needs.• Fielded concerns with suppliers to deliver customized service, cut product displacement time, and expand data analysis.

St Louis, Missouri, Us

Launched nonconformance reduction team to decrease business cost of $25,000 in labor and $150,000 in material by using statistical analysis and key strategic techniques.• Fabricated sampling procedures to decrease labor and inspection cost.• Appraised suppliers by auditing manufacturing sites.• Facilitated internal control team to enrich policies and procedures.• Resolved matters with suppliers to ensure quality service and improve initiative.• Boosted customer satisfaction through corrective action team efforts that removed defect trends.• Redesigned business operations using statistical analysis to amplify product expansion.

New York, Ny, Us

Instituted procedures and management applications to multiply process upgrading and cause a 10% decrease of DPMO.• Centralized OTC/Drug product effectiveness by using equipment studies.• Pioneered Quality by Design techniques to prioritize quality.• Incorporated production improvements to meet the terms of federal and international regulations.• Controlled communication with domestic and international suppliers to ensure timeliness, effective corrective action, and notification of project problems and product rejects.• Compiled tracking system for complaints/feedback to ensure proper handling.

New York, Ny, Us

B.S., Aerospace Engineering

M.S., Engineering Management

Certification, Six Sigma Black Belt

Certification, Lean / Six Sigma Green Belt