Medical Device Development Coordinator

4 days ago

Gold Coast, Queensland, Australia beBeeDesign Full time $90,000 - $120,000

Opportunities abound for a skilled professional to coordinate and support the development of medical devices in Australia.

This role entails overseeing projects from concept through commercialization, ensuring seamless alignment with quality management systems and regulatory requirements.

Key responsibilities include:

  • Coordinating product realization and commercialization efforts.
  • Maintaining accurate documentation pertaining to design and development in compliance with quality and regulatory standards.
  • Representing the organization during internal and external audits.
  • Providing assistance to the Quality and Regulatory department as needed.

The ideal candidate will possess a background in the medical device industry, demonstrated experience with QMS systems, and familiarity with ISO 13485 and 14971. Excellent communication skills, organizational abilities, and teamwork aptitude are also essential.

Responsibilities:

  • Project Coordination: Oversee multiple projects simultaneously, ensuring timely completion and adherence to quality standards.
  • Documentation Management: Maintain accurate and up-to-date records of design and development processes, products, and procedures.
  • Quality Assurance: Participate in internal and external audits, demonstrating expertise in quality management systems and regulatory requirements.
  • Support Functions: Provide administrative support to the Quality and Regulatory department as needed.

Requirements:

  • Background in medical device industry.
  • Demonstrated experience with QMS systems.
  • Familiarity with ISO 13485 and 14971.
  • Excellent communication and organizational skills.
  • Ability to work effectively in a team environment.

What We Offer:

  • A dynamic work environment with opportunities for growth and development.
  • A competitive compensation package.
  • Comprehensive training and support.
  • Professional networking opportunities.

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