Kenneth Hoelle
Product/project Engineer at B. Braun Medical
- Role
- Sr Pfg Suppliier Quality Engineer at B. Braun Medical Inc. (US)
- Location
- Bath, PA, US
- LinkedIn followers
- 500 followers
About Kenneth Hoelle
Certified engineering and operations professional in a regulated medical device industry. Technically oriented quality engineer with extensive knowledge of medical device manufacturing operations and regulations. Proven ability to ensure product requirements and applicable global regulatory approvals are met.
Experience
Sr Pfg Suppliier Quality Engineer
Jan 2019 — Present · Allentown, PA, US
Routine monitoring of suppliers through key performance indicators. Owner of supplier change activities to maintain business continuity. Audit/assessment of current and future suppliers in support of the supplier qualification & monitoring processes. Develops and implements requirements for PFGs.
Education
Centenary University
Associate of Science - AS, Business Administration, Management and Operations
2007 — 2010
Association for the Advancement of Medical Instrumentation (AAMI)
Quality System Requirements and Industry Practice, Biomedical/Medical Engineering
Star Career Academy
Technical Associates Degree, Electrical Engineering Technologies
1994 — 1996
Centenary University
Bachelor of Business Administration (BBA), Business Administration, Management and Operations
2011 — 2013
Association for the Advancement of Medical Instrumentation (AAMI)
Process Validation Requirements and Industry Practice, Biomedical/Medical Engineering
2014 — 2014
Skills
- Continuous Improvement
- Design Control
- Capa
- Iso 14971
- Medical Devices
- Lean Manufacturing
- Iso 13485
- Cqe
- Quality System
- Root Cause Analysis
- V&V
- Gage R&R
- Gmp
- Cqa
- Spc
- Fda
- Iso
- Manufacturing
- Quality Control
- Calibration
- Sop
- Six Sigma
- Quality Assurance
- Validation
- Fmea
- Quality Auditing
- Supplier Quality
- Design of Experiments
- 21 Cfr
- Cross-Functional Team Leadership
- Process Improvement
- Product Development
- Minitab
- Dmaic
- Quality Management
- Management
- Testing
- Engineering
- R&D
- Electronics
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