Senior Quality System Specialist for Process Excellence and Compliance - Remote Opportunity for Experienced Professionals in Quality Assurance and Regulatory Affairs

Introduction to Insulet Corporation

Insulet Corporation, 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 enable 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 our team, we are seeking highly motivated and performance-driven individuals who share our values and are dedicated to exceeding customer expectations.

Job Overview

We are currently seeking a Senior Quality System Specialist to join our team, with a focus on Process Excellence and Compliance. As a Senior Quality System Specialist, you will play a critical role in ensuring quality system compliance within our Production and Process sub-processes, governing related Quality 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 quality system documents and related Quality System documents
• Develop and deploy training programs for quality system documents in collaboration with the Training department
• Review and approve Quality Management System documents and protocols
• Support remediation activities as needed
• Develop workflows in quality systems and support the resolution of issues with nonconformances in various processes
• Support internal and external quality system audits, Root 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 Quality Management curriculum, or equivalent experience
• A minimum of 5-7 years of work experience in Quality Assurance within 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 within a Quality Management System
• Experience in the development and implementation of effective Design Control Systems
• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices
• Fluency in computer skills, including Microsoft Office programs (e.g., Word, Excel, Visio, PowerPoint)
• Ability to effectively communicate with all levels of employees, from front-line operators to Vice Presidents/Executives
• Ability to work independently and follow up with task owners to complete tasks and close out open items
• Familiarity with structured phase-gate 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 Standard
• CQE, CQM, CQA, Greenbelt, or above, and/or PMP certifications
• Strong verbal and written communication skills
• Ability to organize and prioritize tasks
• Able to work effectively in a high-stress, high-energy environment

Career Growth Opportunities and Learning Benefits

At Insulet Corporation, we are committed to the growth and development of our employees. As a Senior Quality System Specialist, you will have the opportunity to work on complex projects, collaborate with cross-functional teams, and develop your skills and expertise in quality assurance and regulatory affairs. You will also have access to training and development programs, including auditor training certification and other industry-recognized certifications.

Work Environment and Company Culture

Our company culture is built on a foundation of shared values, including a commitment to excellence, customer focus, and teamwork. We believe in fostering a positive 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 the company's mission and vision.

Compensation, Perks, and Benefits

The US base salary range 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 provide opportunities for professional growth and development, including training and development programs, and a positive and inclusive work environment.

Conclusion

If you are a motivated and experienced quality assurance professional looking for a new challenge, we encourage you to apply for this exciting opportunity. As a Senior Quality System Specialist at Insulet Corporation, you will play a critical role in ensuring quality system compliance and driving process excellence. Don't hesitate to apply – we value a great attitude and a willingness to learn above all. Submit your application today and join our team of dedicated professionals who are passionate about improving the lives of our customers.