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Quality Systems Specialist
hace 2 meses
Careers that Make a Difference
We're a leading medical technology company with a legacy of integrity and innovation. Our mission is to improve patient care and make healthcare more accessible and affordable worldwide.
A Day in the Life
- Develop and maintain quality programs, systems, processes, and procedures to ensure compliance with policies and standards.
- Provide expertise and guidance on interpreting policies, regulations, and internal guidelines to ensure compliance.
- Work 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, and provide to stakeholders.
- Coordinate legal requests in support of government investigations or litigations.
- Ensure quality assurance programs and policies are maintained and modified regularly.
- Foster uniform standards worldwide and enable best practice sharing to achieve the company's mission globally.
Requirements
- Fluent in English and German
- 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
- Technologist degree related to pharmacy
Our Commitment
We're committed to inclusion, diversity, and equity, and we strive to create a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We believe that equity starts beyond our workplace and we must play a role in addressing systemic inequities in our communities to have long-term sustainable impact.
