
Product Development Quality Leader
3 days ago
Job Title: Design Assurance Program Manager
Location: Ballybrit Upper Industrial Estate, Galway
Key Responsibilities:- Lead Quality Representative on projects and provide guidance to others for establishing appropriate Design History File / Device Master Record documentation.
- Provide detailed planning for clinical, pilot production, and scale-up plans in New Product Introduction programs.
- Ensure project teams utilize relevant regulations and industry standards throughout the product development process.
- Investigate and evaluate material biocompatibility and sterilization methods during product design.
- Conduct risk assessments of the design to determine functionality.
- Responsible for timely Corrective and Preventative Actions (CAPA), change control, internal and vendor audits, product release, document control, and design control process.
- Auditing and qualification of new suppliers may be required.
- Ensure all work satisfies the company's Quality Manual requirements.
- Minimum Bachelor's degree in Engineering or related field.
- 6+ years of medical device design and development/quality assurance experience.
- Ability to lead product verification & validation activities.
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