Design Assurance Quality Lead

23 hours ago

Galway, Galway, Ireland beBeeQuality Full time

Job Title: Design Assurance Quality Lead

About the Role

We are seeking a seasoned quality assurance professional to lead our design assurance program. In this role, you will be responsible for ensuring that all design activities meet the required standards and regulatory requirements.

Key Responsibilities
  1. Lead quality representative on projects, contributing to the development of appropriate design history files and device master records.
  2. Evaluate and implement quality systems, regulations, and industry standards throughout the product development process.
  3. Investigate and evaluate material biocompatibility and sterilization methods during the product design cycle.
  4. Conduct risk assessments to ensure designs can function as intended.
  5. Manage timely corrective and preventative actions, change control, and notifications.
  6. Interact with customers and suppliers in a professional manner, ensuring effective communication and audit qualification.
  7. Solve technical issues and ensure all work satisfies the quality manual.
Requirements
  1. Bachelor's degree in Engineering or related field.
  2. 6+ years of medical device design and quality assurance experience.
  3. Strong customer relationship management and communication skills.
  4. Able to interact professionally with client companies.
  5. Proven ability to lead product verification and validation activities.
  6. Experience working with operations to develop manufacturing process instructions and operator training.
What We Offer

This is an exciting opportunity to join our team and contribute to the development of innovative medical devices. If you have a passion for quality assurance and a desire to make a difference, we encourage you to apply.

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