Design Assurance Program Manager Job Description
The role of a Design Assurance Program Manager involves leading the development and implementation of quality assurance programs for medical device design and development. This includes establishing and maintaining design history files, ensuring compliance with regulatory requirements, and coordinating with cross-functional teams to ensure timely and effective product launches.
* Lead Quality Representative on projects, contributing and/or providing guidance to establish appropriate documentation.
* Provide detailed planning for clinical, pilot production, and scale-up plans in New Product Introduction programs.
* Ensure project teams utilize Nordson Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
* Investigate and evaluate material biocompatibility and appropriate methods of sterilization during the product design cycle.
* Conduct risk assessments of the design to determine the ability to function as intended.
Required Skills and Qualifications:
* Minimum Bachelor's degree in Engineering or related field.
* 6+ years of medical device design and development/quality assurance experience is required.
* Manage customer relationships and responses in a timely manner.
* Ability to interact with client companies in a professional manner.
* Demonstrated ability to lead product verification & validation activities.
Benefits:
* Hourly rate contract.
* 3 days a week (Part-time).
* Hybrid working.
If you are looking for a challenging and rewarding career opportunity, consider this Design Assurance Program Manager role.