QA Manager

Há 3 dias

São Paulo, São Paulo, Brasil beBeeQualityManagement Tempo inteiro US$90.000 - US$125.000

Job Opportunity:

This is a challenging role for a Quality Management professional who can lead the QA Department and manage all QA functions at the Plant. The ideal candidate will have experience working with cross-departmental leadership to deliver high-quality and compliant products on schedule.

The successful applicant will establish and maintain a QMS to ensure that facilities, equipment, personnel, methods, processes, procedures, and products comply with applicable corporate guidelines, local, national, and international regulatory standards, and GMP.

Key responsibilities include providing leadership and direction for the organization's QMS and processes, defining and promoting a quality mindset across the entire company, and assisting in the definition of company goals and objectives.

The position also involves managing FDA inspections for Medical Device manufacturing plants, utilizing problem-solving skills and product quality improvement techniques.

In terms of qualifications, the ideal candidate will have a degree in Science, Engineering, or equivalent, along with a minimum 5 years of experience managing a Quality Department in the Medical Device industry for healthcare.

Other essential skills include hands-on experience with Quality System Standards, good knowledge of ISO 9001, ISO 13485 (medical devices), 21 CFR, REACH, GMP, and QMS requirements, auditor qualification, process control, and effective manufacturing/QA control.

A strong commercial focus, results-driven approach, and ability to work independently are also highly valued.

Additionally, excellent interpersonal and organizational skills, self-motivation, and the ability to build strong relationships with suppliers, internal customers, and cross-functional departments are necessary for success in this role.

Besides these qualities, an innovative approach to process improvement and problem-solving, as well as proven global team player skills, are highly desirable.

Requirements:

  • Education: Degree in Science, Engineering, or equivalent.
  • Experience:
    • Minimum 5 years of experience managing a Quality Department in the Medical Device industry for healthcare.
    • Experience managing FDA inspections for Medical Device manufacturing plants.
    • Problem solving and product quality improvement experience.
  • Skills:
    • Hands-on experience with Quality System Standards.
    • Good knowledge of ISO 9001, ISO 13485 (medical devices), 21 CFR, REACH, GMP, and QMS requirements.
    • Auditor qualification.
    • Process control and effective manufacturing/QA control.
    • Analytical skills and attention to detail.
  • Desirable Competencies:
    • Leadership:
      • Embraces new technologies, shares knowledge, achieves department goals/KPIs, motivates teams, maintains strong connections, provides training, demonstrates urgency and commitment to project timelines.
    • Teamwork:
      • Builds strong relationships with suppliers, internal customers, and cross-functional departments.
    • Communication:
      • Effective written and verbal communication skills in English, capable of engaging across all levels and geographies, providing and receiving constructive feedback.
    • Interpersonal:
      • Good interpersonal and organizational skills; self-motivated and independent.
      • Proven global team player, effective with team members, internal partners, and suppliers.
      • Proactive, results-oriented, focusing on quality, cost savings, flexibility, and risk management.

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