Oversee the quality support for the development and industrialization of Medical Devices and Delivery Systems. Responsible for the development of the strategy, organizational structure and execution of the Quality support for the development organization specifically for Med. Device/ Delivery Systems.
location: Scottsdale, Arizona
job type: Permanent
salary: $145,000 - 150,000 per year
work hours: 9 to 5
- Create Quality strategy to support Medical Device development and Industrialization
- Develop the organizational structure and talent to execute the Quality strategy
- Establish and/ or revise processes, procedures, and metrics to support the Medical Device development process
- Assure that Medical Devices/ Delivery Systems are developed in a compliant manner with all applicable standards, procedures and regulations
- Directs and manages quality control, quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible.
- Manage and maintain an effective Quality Assurance program in alignment with Global Operating Procedures and capable of maintaining ISO 15378 and 13458 certification status.
- Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations
- Ensures timely resolution to customer inquiries (audit findings and complaints)
- Achieves quality objectives by contributing information and analysis to strategic plans and reviews.
- Conduct routine quality project management reviews with project Teams and management
- Conduct site Quality Management Review meetings of the site quality system
- Establish and monitor site Quality Metrics used to evaluate the effectiveness of the Quality System
- Assure proper use of change management associated with validated processes and Design Control process.
- Assure execution of internal audit program
- Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
- Performs other duties as assigned based on business needs
- Bachelor's degree - Science or Engineering
- Minimum 10 years of experience in Medical Device development and /or manufacturing
- Experience / knowledge of FDA CFR 820 - Medical Devices
- Experience / knowledge of ISO 13485 Medical Device Quality Systems
- Experience / knowledge of EU Medical Device Regulations (MDR)
- Able to be aware of all relevant SOPs as per Company policy
- Able to comply with the company's safety policy at all times
- Able to comply with the company's quality policy at all times.
skills: Quality Assurance, GMP (Good Manufacturing Practice), Medical Device Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.