Senior Quality Assurance Manager
Há 3 dias
Leads a team responsible for ensuring the quality of products and processes at a manufacturing site. This involves managing all aspects of the QA function, working closely with cross-functional teams to deliver high-quality products that meet regulatory standards and customer requirements.
Key Responsibilities:- Develops and maintains a quality management system (QMS) to ensure compliance with relevant corporate guidelines, regulatory standards, and good manufacturing practices (GMP).
- Provides leadership and direction for the organization's QMS and processes, promoting a culture of quality excellence throughout the company.
- Collaborates with stakeholders to define business objectives and develop strategies to achieve them, while ensuring that quality standards are met and exceeded.
Requirements:
- Bachelor's degree in Science or Engineering.
- A minimum of 5 years of experience in managing a Quality Department in the Medical Device industry.
- Proven track record of successfully managing FDA inspections for Medical Device manufacturing plants.
- Familiarity with quality system standards, including ISO 9001, ISO 13485, 21 CFR, REACH, and GMP.
- Auditor qualification and process control skills.
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