David vander Meulen
Consultant, quality compliance audits; Pharmaceutical QC/QA & stability
- Role
- Consultant at Qualifyze
- Location
- Dallas-Fort Worth, TX, US
- LinkedIn followers
- 500 followers
About David vander Meulen
Lead Auditor - On-Site, Remote, Internal audits• Quality Management Systems; Quality Systems• Quality Assurance; CAPA; Quality Control • Organizational Performance Excellence• Compliance: Regulatory, Analytical Development, Supplier Quality Assurance; Pharmaceutical Stability* Supplier & Laboratory Audits: ISO13485; ISO9001; ISO 15378; GMP/GLP; EU GMP• Management/Supervision; Training Development• Technical Writing; ProofreadingSpecialties:* Projects in healthcare products and service/ regulated industry (FDA, GxP, ISO, medical device)* 20••••12 Examiner for TN Center for Performance Excellence (Baldrige Criteria)* 2011 Exam Reviewer for Certified Manager of Quality/Organizational Excellence exam* ASQ-CMQ/OE: Certified Manager of Quality/Organizational Excellence (#13095)* ASQ-CQA: Certified Quality Auditor (#42468)
Experience
Consultant
Dec 2021 — Present · Dallas-Fort Worth, TX, US
Lead Auditor for Qualifyze; ISO 9001, ISO 15378, ISO 17025; Supplier and Laboratory Auditing; GMP, GLP;Pharmaceutical compliance services
Education
Central College
BA, Physics
University of Illinois Urbana-Champaign
PhD, Biophysics
Skills
- Medical Devices
- Capa
- Hplc
- Continuous Improvement
- Biotechnology
- Iso
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Fda
- Cgmp
- Six Sigma
- Gxp
- Quality Auditing
- Pharmaceutics
- Laboratory
- Biopharmaceuticals
- Lean Manufacturing
- Glp
- Life Sciences
- Iso 13485
- Uv/Vis
- Quality Control
- Software Documentation
- Root Cause Analysis
- Gmp
- Process Improvement
- Change Control
- Lean Sigma
- Validation
- Validations
- Qc
- Analytical Chemistry
- R&D
- Quality Assurance
- Regulatory Affairs
- Lifesciences
- 21 Cfr Part 11
- Pharmaceuticals
- Cqa
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