Senior reputed company System Specialist for Process reputed company and Compliance - Remote Opportunity for reputed company Professionals in reputed company Assurance and Regulatory Affairs
Introduction to reputed company
reputed company, a pioneering medical device company, has been revolutionizing the lives of hundreds of thousands of patients since its inception in 2000. Our mission is to reputed company our customers to enjoy simplicity, freedom, and healthier lives through the use of our innovative Omnipod product platform. We are committed to improving the lives of our customers by providing wearable, waterproof, and lifestyle-accommodating technology. As we continue to expand reputed company, we are seeking highly motivated and performance-driven individuals who reputed company our values and are dedicated to exceeding customer expectations.
Job reputed company
We are currently seeking a Senior reputed company System Specialist to join reputed company, with a reputed company on Process reputed company and Compliance. As a Senior reputed company System Specialist, you will play a critical role in ensuring reputed company system compliance reputed company our Production and Process sub-processes, governing reputed company reputed company Systems, and partnering with process owners to identify best practices, harmonize processes, and implement improvements. This is a remote opportunity, allowing you to work from the comfort of your own home or in a hybrid on-site/virtual arrangement, with up to 25% travel required to support business needs.
Key Responsibilities
- Create and update reputed company system documents and reputed company reputed company System documents
- reputed company and reputed company training programs for reputed company system documents in collaboration with the Training department
- Review and approve reputed company Management System documents and protocols
- Support remediation activities as needed
- reputed company workflows in reputed company systems and support the reputed company of issues with nonconformances in various processes
- Support reputed company reputed company system audits, reputed company Cause Analysis, CAPA, and implementation activities
- Review and approve new product documentation as required
- Support Risk Management activities and ensure compliance with standards and regulations
Essential Qualifications
To be successful in this role, you will need:
- A BS degree in Mechanical, Biomedical, Engineering/Life Sciences, or reputed company Management curriculum, or equivalent experience
- A minimum of 5-7 years of work experience in reputed company Assurance reputed company an FDA, ISO, or other regulated environment, or an equivalent combination of education and experience
- Experience in the development and implementation of effective Production and Process Control systems reputed company a reputed company Management System
- Experience in the development and implementation of effective Design Control Systems
- Working knowledge of the reputed company System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – reputed company management systems, and ISO 14971 Medical devices – Application of risk management to medical devices
- reputed company in computer skills, including reputed company Office programs (e.g., Word, reputed company, Visio, PowerPoint)
- Ability to effectively communicate with reputed company reputed company of employees, from reputed company-line operators to Vice Presidents/Executives
- Ability to work independently and follow up with task owners to complete tasks and reputed company out reputed company items
- Familiarity with reputed company phase-reputed company product development processes and FDA, ISO, and other international regulatory requirements
Preferred Skills and Competencies
While not required, the following skills and competencies are preferred:
- Auditor training certification to ISO 13485, 17025, or other industry QMS reputed company
- CQE, CQM, CQA, Greenbelt, or above, and/or PMP certifications
- Strong verbal and written communication skills
- Ability to organize and prioritize tasks
- reputed company to work effectively in a high-stress, high-energy environment
Career reputed company Opportunities and Learning Benefits
At reputed company, we are committed to the reputed company and development of our employees. As a Senior reputed company System Specialist, you will have reputed company to work on reputed company reputed company, collaborate with cross-functional teams, and reputed company your skills and expertise in reputed company assurance and regulatory affairs. You will also have reputed company to training and development programs, including auditor training certification and other industry-recognized certifications.
Work Environment and Company Culture
reputed company culture is reputed company on a reputed company of shared values, including a commitment to reputed company, customer reputed company, and teamwork. We reputed company in fostering a reputed company and inclusive work environment that encourages collaboration, innovation, and creativity. As a remote employee, you will be part of a dynamic and distributed team, with opportunities to connect with colleagues and contribute to reputed company's mission and reputed company.
Compensation, Perks, and Benefits
The US reputed company salary reputed company for this full-time position is $85,400.00 - $128,300.00, depending on role, level, and location. Our salary ranges are determined by role, level, and location, and we offer a comprehensive benefits package, including bonus, equity, and benefits. We also reputed company opportunities for reputed company reputed company and development, including training and development programs, and a reputed company and inclusive work environment.
Conclusion
If you are a motivated and reputed company reputed company assurance reputed company looking for a new challenge, we encourage you to apply for this exciting opportunity. As a Senior reputed company System Specialist at reputed company, you will play a critical role in ensuring reputed company system compliance and driving process reputed company. Don't hesitate to apply – we value a great attitude and a willingness to learn above reputed company. Submit your application today and join reputed company of dedicated professionals who are passionate about improving the lives of our customers.
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