Experience

Chemence Medical, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• • Jul 2020 - Present

• • Mar 2019 - Jul 2020

• • Apr 2015 - Jul 2020

  • Represent Chemence Medical Inc. during medical device regulatory agency audits, field complaint investigations and inspections. Serve as Quality representative to product development teams and proactively interact with internal functional areas, corporate partners, and contract manufacturers.• Promote organization’s adherence to industry standards in regard to product assurance, validations, design controls, document and data controls, supplier management, etc. • Maintain excellent working relationships with the FDA, other Health Authorities, internal project team members, collaborators/partners and contract manufacturers. • Oversee internal quality system audits, supplier quality audits, due diligence audits.• Responsible for initiating investigations resulting from non-conformance’s, concession applications or corrective actions, technical documentation of investigation results, and preparing correspondences to regulatory authorities as needed.• Assist in the development, issuance and control of all written procedures and product documentation for the company, ensuring that they comply with the requirements of the company, cGMP's, and the regulatory agencies.• Provide guidance and training on cGMP issues, interpretation of the regulations, and maintain awareness of regulatory trends and industry practices. • Ensure the release of product/s manufactured by Chemence Medical Products, Inc. within established timeframes required to meet company objectives.• Maintain individual and group training records. Facilitate group training as required. • Provide support with compliance and quality assurance decisions as needed to: QA, Operations, R&D, Sales and Marketing, Technology and Executive Management.• Identify and lead initiatives in support of continuing improvement in quality as it relates to quality and customer service.• Lead product QA release activities of finished goods, intermediates and raw materials Show less



Chemence

• Chemical Manufacturing
• 1 - 100 Employee

• QC Chemist/QA Supervisor

  • Sep 2013 - Present



MWH, now part of Stantec

• United States
• Civil Engineering
• 700 & Above Employee

• Senior Analytical Chemist

  • Sep 2008 - Mar 2013



CIBA Vision

• Medical Equipment Manufacturing
• 700 & Above Employee

• Analytical Chemist

  • Aug 2004 - Sep 2008