Design and Quality Assurance Manager
2 weeks ago
**Quality Assurance Manager - Medical Devices**: We have an exciting opportunity for a highly motivated and experienced Design and Quality Assurance Manager to join our team. The successful candidate will be responsible for leading quality assurance efforts on projects, ensuring project teams utilize company quality systems and regulations throughout the product development process.
**Responsibilities include:
- Leading Quality Representative on projects, contributing and/or providing guidance to establish appropriate Design History File / Device Master Record documentation.
- Ensuring project teams utilize Nordson Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
- Investigating and evaluating material biocompatibility and appropriate methods of sterilization during the product design cycle.
- Conducting risk assessments of the design to determine the ability to function as intended.
- Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process, and design history files (DHF), device master records, etc.
**Key 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.
- Ability to interact with client companies in a professional manner.
- Demonstrated ability to lead product verification & validation activities.
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