Job Summary
Position Overview:This position is responsible for Design Control to ensure current products and new projects meet the regulatory and quality requirements for medical devices. Interfaces with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. Effectively communicate design and development regulations, optimizing development, review and/or approval of design documents and protocols and ensuring ambiguities and conflicting requirements are resolved are critical to the success of the position.
Position Overview:
This position is responsible for Design Control to ensure current products and new projects meet the regulatory and quality requirements for medical devices. Interfaces with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. Effectively communicate design and development regulations, optimizing development, review and/or approval of design documents and protocols and ensuring ambiguities and conflicting requirements are resolved are critical to the success of the position.
Responsibilities:
• Responsible for Design Control initiatives to develop appropriate Design History File documents. Review and approve new product documentation, as required.
• Collaborate with Project Management to optimize Design Control process and develop Sustaining Quality Engineering process.
• Review and approve Design Control documents and protocols.
• Serve as the Design Control expert to organization.
• Develop and deliver Design control training for organization.
• Support CAPA activities
• Support Risk Management activities and ensure compliance to standards and regulation
• Performs other duties as assigned.
Education and Experience:
Minimum Requirements:
• BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience.
• A minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
• 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.
• Working knowledge of EN 60601, Safety requirements for medical electrical systems.
• Working knowledge of ISO 62304, Medical Device Software – Software Life Cycle Process
• Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).
• Demonstrated experience organizing and maintaining large documentation sets.
• Ability to follow up with task owners to close out open items.
• Familiarity with structured phase-gate product development processes.
• Familiarity with FDA, ISO, and other international regulatory requirements.
Preferred Skills and Competencies:
• Effective verbal and written communication skills.
• Experience collaborating and communicate with individuals at multiple levels in an organization.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Skilled in computer use including word processing, spreadsheet, and database applications.
• Able to work effectively in a high-stress, high-energy environment.
Physical Requirements:
• Travel as required to support business needs
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
