Senior Quality Systems Specialist
hace 1 mes
Careers that Make a Difference
We're a leading medical technology company with a legacy of integrity and innovation. We're committed to making healthcare more affordable and accessible worldwide. As a Senior Quality Systems Specialist, you'll play a key role in ensuring the quality and performance of our services meet the highest standards.
A Day in the Life
- Provide oversight and guidance on the development and maintenance of quality programs, systems, and processes to ensure compliance with policies and regulatory requirements.
- Offer expertise and support in interpreting policies, regulations, and internal guidelines to ensure compliance.
- Collaborate with operating entities to provide process analysis and oversight to enforce requirements and meet regulations.
- Lead audit and inspection preparation, resolution of findings, and liaison with auditing groups and inspectors.
- Prepare reports and documentation, including Corrective and Preventative Actions, and provide to stakeholders.
- Coordinate requests in support of government investigations or litigations.
- Maintain and update quality assurance programs and policies regularly.
- Foster uniform standards and best practice sharing to achieve the company's mission globally.
Requirements
- Fluent in English and Italian languages.
- High degree of organization and prioritization skills.
- Ability to work in a fast-paced environment with high attention to detail and follow-through.
- Strong relationship building, communication, and interpersonal skills.
- Proactive and good customer service skills.
- Team player.
- Strong critical thinking and analytical skills.
- Strong project management and critical thinking skills.
Preferred Qualifications
- 1 year of experience working with quality systems or related areas.
- Medical Device Industry experience.
- Knowledge with MS office (Outlook, Word, Excel, PowerPoint, etc.).
- Previous experience supporting quality system audits.
- Strong technical writing and documentation review skills.
- Independent compliance decision maker.
- Good understanding of Medical Device Regulations and the Food and Drugs Acts.
Our Commitment We're committed to inclusion, diversity, and equity, with a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We drive ID&E forward to enhance employee well-being and accelerate innovation that brings our technologies to more people worldwide.
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