Senior Quality Assurance Specialist
Há 4 dias
This role is responsible for providing support to the Quality Assurance and Regulatory Affairs departments within the company's logistics and distribution center.
The Technical Director will provide guidance on Technovigilance, local labeling processes, document control, and quality systems training in accordance with internal procedures, external regulations, and international standards.
The position will also be responsible for establishing metrics, analyzing trends, and reporting on employee training compliance data.
Additionally, the Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, investigations, product development planning, and regulatory agency interaction.
The role will involve mentoring and developing staff members as part of the team.
Required Skills & Qualifications- BS or BA degree in Engineering, Science, or a related field;
- A minimum of 7 years of professional experience in coordinating logistics, warehousing, customs, and transportation processes;
- Complete knowledge with ANMAT, FDA, cGMP, and ISO quality system requirements for a diverse medical device manufacturer;
This role offers the opportunity to work with a global organization that values innovation and quality.
The position provides a challenging and dynamic work environment, with opportunities for growth and development.
OthersThis role requires strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills.
The ideal candidate will be a strategic thinker, with the ability to develop and implement effective solutions.
The position involves working closely with cross-functional teams, including sales, marketing, and operations.
The successful candidate will have a strong understanding of regulatory requirements and industry standards.
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