Quality Manager

Ansell; São Paulo; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A leading provider of protection solutions seeks a Quality Assurance Manager to oversee QA functions at the manufacturing plant. This role includes establishing compliance with regulatory standards, leading a Quality Management System, and fostering a strong quality mindset across the organization. The ideal candidate must have substantial experience in the Medical Device industry and a degree in a relevant field.

Serviços

Professional development opportunities

Competitive salary

Health benefits

Qualificações

• Minimum 5 years managing a Quality Department in Medical Devices.
• Experience with FDA inspections and QMS requirements.
• Hands-on experience with ISO 9001 and ISO 13485.

Responsabilidades

• Lead the QA Department and manage all QA functions.
• Establish and maintain a Quality Management System.
• Provide leadership and direction for QMS and processes.

Conhecimentos

Analytical skills

Attention to detail

Problem solving

Leadership

Communication

Formação académica

Degree in Science, Engineering, or equivalent

Ferramentas

Statistical techniques

Quality System Standards

SPC

Six Sigma (Green Belt)

Descrição da oferta de emprego

GENERAL SUMMARY OF POSITION

Lead the QA Department and manage all QA functions at the Plant (manufacturing site), working with cross-departmental leadership to deliver high-quality and compliant products on schedule.

Establish and maintain a QMS to ensure that the company's facilities, equipment, personnel, methods, processes, procedures, and products comply with applicable corporate guidelines, local, national, and international regulatory standards, and GMP.

Provide leadership and direction for the organization’s QMS and processes, and define and promote a quality mindset across the entire company.

Assist in the definition of company goals and objectives, and help control QA budgets to ensure achievement of financial plans while meeting customer and regulatory/legislative requirements.

KEY POSITION REQUIREMENTS

Education

Degree in Science, Engineering, or equivalent.

Job 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.
• Experience in problem solving and product quality improvement.
• Ability to work independently, in a structured and systematic manner.
• Experience with statistical techniques and process improvement tools used in manufacturing, e.g., SPC, Six Sigma (Green Belt).

Knowledge and 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.
• Good analytical skills and attention to detail.
• Results-driven with a strong commercial focus.

Desirable Job Competencies

Leadership

Embraces new technologies, shares knowledge, achieves department goals/KPIs, motivates teams, maintains strong connections within Ansell, provides training, and 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.
• Delivers high-quality, consistent work.
• Innovative in process improvement and problem-solving.

Ansell is a leading global provider of protection solutions. Our company designs, develops, and manufactures a wide range of protection solutions that meet the evolving needs of our markets and industries. Protection is our primary concern, as millions of people worldwide depend on Ansell in their professional and personal lives.

Our vision is to create a world where people can enjoy optimal protection against the risks they face. Whether at work or during leisure, people need the right protection for the right application. Increased safety, security, and productivity are the best guarantees of effective protection.