Job Title: Design Assurance Program Manager
At our company, a global leader in the medical device industry and expert in design, development, and manufacturing of complex medical devices and component technologies, we are seeking a highly skilled Design Assurance Program Manager.
This is a part-time hourly rate contract position (3 days a week), offering hybrid working arrangements.
Key Responsibilities:
* Lead Quality Representative on projects, guiding teams to establish comprehensive Design History File/Device Master Record documentation.
* Develop detailed plans for clinical, pilot production, and scale-up phases in New Product Introduction programs.
* Ensure project teams utilize Nordson Medical Quality Systems, adhering to relevant regulations and industry standards throughout product development.
* Investigate material biocompatibility and sterilization methods during the product design cycle.
* Conduct risk assessments to ensure designs function as intended.
* Oversee timely Corrective and Preventative Actions, change control, notification, internal and vendor audits, product release, document control, design control process, and design history files.
* Interact with customer and supplier companies professionally, maintaining an ongoing exchange of information.
* Audit and qualify new suppliers as needed.
* Resolve technical issues effectively and ensure all work satisfies the Quality Manual requirements.
* Continuously identify opportunities for improvement and compliance enhancement.
Skill Requirements:
* Minimum Bachelor's degree in Engineering or related field.
* 6+ years of medical device design and development/quality assurance experience.
* Proven ability to manage customer relationships and respond promptly.
* Effective interaction with client companies.
* Demonstrated leadership in product verification and validation activities.
* Experience working with operations to develop strong manufacturing process instructions and operator training.