Job Title: Design Assurance Lead
Job Overview:
* Lead Quality Representative on projects to ensure accurate and comprehensive design history files and device master records are properly documented.
* Develop strategic plans for clinical, pilot production, and scale-up initiatives within New Product Introduction programs.
* Ensure project teams utilize quality systems and relevant regulations throughout product development processes.
Responsibilities:
* Conduct thorough investigations and evaluations of material biocompatibility and sterilization methods during product design phases.
* Perform risk assessments to determine design functionality and identify potential areas for improvement.
* Implement corrective actions, change control, internal audits, and product release procedures.
* Engage with customers and suppliers in a professional manner, conducting audits and qualifying new vendors as necessary.
Requirements:
* Bachelor's degree in Engineering or related field.
* A minimum of 6 years' experience in medical device design and quality assurance.
* Demonstrated ability to lead product verification and validation activities effectively.