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Product Development Quality Lead

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €100,000

Job Title: Design Assurance Program Manager

Overview

We are seeking a seasoned professional to lead our Design Assurance Program. The ideal candidate will have a strong background in quality assurance, excellent leadership skills, and the ability to drive results.

Responsibilities
  • Lead Quality Representative on projects, contributing and/or providing guidance to establish appropriate Design History File / Device Master Record documentation.
  • 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.
  • 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.
  • Interact with customer and supplier companies in a professional manner; proactively communicate to ensure an ongoing two-way exchange of information.
Requirements
  • 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.
  • Experience working with operations to develop strong manufacturing process instructions and operator training is desired.
Benefits

Hourly rate contract, 3 days a week (Part-time), Hybrid working.

If you're looking for a challenging role that utilizes your expertise, we encourage you to apply.