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Manager, Quality Assurance
Teladoc - Harrison, NY
posted about 2 months ago
About the position
The Manager, Quality Assurance at Teladoc Health is responsible for overseeing quality assurance processes within the fulfillment and kitting operations at the Lewisville site. This role involves leading a quality team, conducting quality control inspections, and ensuring compliance with quality management systems for medical devices. The manager will collaborate cross-functionally with various teams to maintain high-quality standards and drive continuous improvement initiatives.
Responsibilities
- Lead and manage all aspects of quality assurance at the manufacturing site.
- Conduct all quality control inspections including incoming, in-process, and final inspections.
- Establish and maintain calibration, preventive maintenance, and validation programs.
- Oversee CAPA and Nonconformance processes for Operations Quality.
- Collaborate with R&D and Design Quality teams for new product development launches and design changes.
- Partner with Supplier Quality Engineering on quality-related issues from suppliers.
- Manage Material Review Board (MRB) processes including product disposition.
- Assess risk in manufacturing processes using PFMEA tools.
- Provide leadership, guidance, and mentorship to direct reports.
- Support customer complaint investigations as required.
- Identify, measure, monitor, and improve Quality metrics.
- Support internal and external audits.
Requirements
- Bachelor of Science in Biomedical Engineering, Biotechnology, or foreign equivalent.
- 7 years of experience in Quality Engineering roles within the medical device industry.
- Experience with Quality Management Systems including 21 CFR 820, ISO 13485, or ISO 14971.
- Proficiency in Statistical Process Control (SPC) methodology including Minitab.
- Experience in root cause analysis and associated tools (5 Whys, fishbone diagram, Pareto analysis, Fault Tree analysis).
- Knowledge of Gage R & R studies and Continuous Improvement tools (A3, Value Stream Mapping, Kaizen events, Gemba walks).
- Experience in process validation including Installation Qualifications, Operational Qualifications, and Performance Qualifications.
Benefits
- Competitive salary ranging from $150,280 to $196,000 per year.
- 100% telecommuting option.
