Design Assurance Program Manager Position Overview
We are seeking an experienced Design Assurance Program Manager to lead our quality initiatives. This key role will be responsible for ensuring that project teams utilize our Quality Systems and relevant regulations throughout the product development process.
The ideal candidate will have a minimum Bachelor's degree in Engineering or a related field, 6+ years of medical device design and development/quality assurance experience, and excellent communication skills.
Key Responsibilities:
* Lead design history file/device master record documentation and clinical, pilot production, and scale-up plans in New Product Introduction programs.
* Ensure compliance with quality systems, regulations, and industry standards.
* Investigate material biocompatibility and sterilization methods during product design cycles.
* Conduct risk assessments and implement Corrective and Preventative Actions (CAPA), change control, internal and vendor audits, product release, document control, and design history files.
* Communicate with customers and suppliers, auditing, and qualifying new suppliers as needed.
* Resolve technical issues and ensure work meets our Quality Manual requirements.
* Identify improvement opportunities and lead quality roles on client programs.
Requirements:
* Bachelor's degree in Engineering or a related field.
* 6+ years of medical device design and development/quality assurance experience.
* Excellent communication skills.