Steve Pendleton
Quality Assurance Manager, Process Improvement Practitioner, Growth Culture Builder
- Role
- Quality Assurance Manager (Client Support) at Catalent
- Location
- Bloomington, IN, US
- LinkedIn followers
- 500 followers
About Steve Pendleton
Continuous Improvement in medical device manufacturing & quality environment.Specialties: Coaching & leading others, communication, technical writing, & Lean Six Sigma.
Experience
Quality Assurance Manager (Client Support)
Jul 2022 — Present · Bloomington, IN, US
Management of QA Client Support teams responsible for Customer Complaint Investigations, Quality Agreements, New Product Assessments, and Change Requests.
Education
University of Indianapolis
Bachelor of Science (BS), Secondary Education and Teaching
1995 — 1999
Skills
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Catheters
- Lean Manufacturing
- Biotechnology
- Product Development
- Technology Transfer
- Root Cause Analysis
- Quality System
- V&V
- Surgical Instruments
- Regulatory Affairs
- Process Simulation
- Drug Delivery
- Iso 13485
- Cleaning Validation
- 21 Cfr Part 11
- Regulatory Requirements
- Six Sigma
- Product Launch
- Quality Auditing
- Aseptic Processing
- Chemistry
- Biomedical Engineering
- Minitab
- Commercialization
- Capital Equipment
- Quality Assurance
- Design for Manufacturing
- Quality Control
- Gmp
- Injection Molding
- R&D
- Design Control
- Technical Writing
- Leadership
- Validation
- Cross-Functional Team Leadership
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