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.

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.

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