Sarah Waddell
Global Director of Quality at TekniPlex
- Role
- Global Director of Quality at TekniPlex
- Location
- Grand Rapids, MI, US
- LinkedIn followers
- 500 followers
About Sarah Waddell
Experienced global quality leader with 20 years in medical device, pharmaceutical, packaging, and nutrition industries. Known for strong organizational skills, strategic thinking, and a record of increasing responsibility and impact. Skilled in leading global teams, managing quality systems (ISO 13485, ISO 9001, ISO 15378), and ensuring FDA and international compliance. Proven in driving continuous improvement, overseeing contract manufacturers, and fostering high-performing, collaborative teams.
Experience
Global Director of Quality
May 2024 — Present
Education
Kalamazoo College
Bachelor of Arts, Biology
2001 — 2005
Eastern Michigan University
Master's Degree, Quality Management
2012 — 2014
Skills
- Capa
- Continuous Improvement
- 21 Cfr Part 11
- Pharmaceutical Industry
- Sop
- Fda
- Corrective and Preventive Action (Capa)
- Glp
- Quality System
- Cqt
- Internal Audit
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Cssgb
- Change Control
- Gmp
- Sap
- Hplc
- Quality Management
- Trackwise
- Laboratory
- Analytical Chemistry
- Six Sigma
- Quality Auditing
- Aseptic Processing
- Chemistry
- Asq Member
- Supervisory Skills
- Performance Management
- Wet Chemistry
- Standard Operating Procedure (Sop)
- Electronic Lab Notebooks
- U.s. Food and Drug Administration (Fda)
- Chemstation
- Quality Assurance
- Gas Chromatography
- Uv/Vis Spectroscopy
- Microbiology
- Ftir
- Chromatography
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