Surgical Guide Quality Assurance Specialist

5 days ago

Sydney, New South Wales, Australia beBeeExpertise Full time $120,000 - $150,000
Quality Engineer – Surgical Guides

  The role of quality engineer for surgical guides requires a seasoned professional with direct expertise in the design, manufacturing, or quality control of surgical guides.

Key Responsibilities:

  Audit Readiness: Ensure seamless compliance and readiness for regulatory milestones through meticulous planning and coordination.

  Compliance Expertise: Leverage extensive knowledge of 510(k) submissions to drive success in regulatory approvals.

  Surgical Guide Experience: Possess hands-on experience in the development, testing, and implementation of surgical guides.

  Team Leadership: Lead cross-functional teams to achieve strategic objectives and foster collaboration.

Requirements:

  Qualifications:

  Must-Have Qualifications:

  • Proven track record of successful 510(k) submissions
  • Hands-on experience in surgical guide design, manufacturing, or quality control
  • Direct surgical guide expertise
  • Strong leadership and team management skills

  Preferred Qualifications:

  • Master's degree in a relevant field
  • 5+ years of experience in quality engineering or a related field

  Skills:

  Technical Skills:

  • Proficient in regulatory requirements and industry standards
  • Experience with quality management systems (QMS)

  Soft Skills:

  • Excellent communication and interpersonal skills
  • Strategic thinking and problem-solving abilities
What We Offer:

  Competitive Salary: A competitive salary package that reflects your skills and experience.

  Opportunities for Growth: Career advancement opportunities within our organization.

  Collaborative Work Environment: A dynamic and collaborative work environment that fosters innovation and teamwork.

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