Position Overview:

Provides strategic management for Quality Document Services at Insulet.Partners with stakeholders to ensure an effective and efficient document change management process that meets the needs of the business. Responsible for establishing relevant Key Performance Indicators that support quality and business objectives.Drives continuous improvement and develops programs to increase the process efficiency and scalability for business growth.Ensures applicable QMS regulatory requirements and standards are incorporated into the QMS Process for Document and Records Controls and is responsible for ongoing compliance.

Responsibilities:

• Serves as QMS Process Group Owner for Document, Record & Change Controls.
• Leads the development and roll-out of document control tools.
• Lead implementation of Change Order Training & Certification Program.
• Provides oversight of project contractors and vendor resources.
• Supports business initiatives, identify trends and recommends and implements best practices to ensure scalability and growth.
• Maintains a watchful and alert attitude toward the Document Control process, including developing routine reports and metrics to gauge success. Provide inputs to Monthly Data Analysis and Management Review, as required.
• Leads or participates as the QMS representative in Document & Record Control improvement projects.
• Works cross-functionally to improve the content in change orders for approval.
• Manages and develops document control staff at various levels.
• Creates a strong, high performing team with a collaborative culture and customer centric mindset.
• Performs other duties, as required.

Education and Experience:

Minimum Requirements:

• Typically requires a four-year degree from an accredited University or a combination of education and relevant work experience.
• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) ISO 13485 quality system standards. Experience with
• A minimum of 10 years' work experience in a regulated industry, preferably medical device, minimum of 5 years in a Quality Assurance or Regulatory Affairs role, minimum of 5 years of managerial experience.
• FDA and ISO 13485 Certification inspections.
• Working knowledge of 21 CFR Part 11 and experience with implementation of compliant systems.
• Working knowledge of Microsoft Office programs (e.g. Word, Excel, Access, and PowerPoint).
• Experience leading improvement projects

Preferred Skills and Competencies:

• Experience in implementing or enhancing electronic document control systems.
• Effective verbal and written communication skills.
• Ability to communicate at multiple levels of an organization.
• Ability to generate and maintain organized and accurate records.
• Ability to manage, organize tasks and judge priorities.
• Ability to interface with a variety of people with different technical levels and educational backgrounds; must be detail-oriented and highly organized; and must be able to produce accurate and timely results while maintaining a customer-service attitude.
• Must instill a "can-do" spirit within the Document Control Specialist staff: inspiring them to produce consistently accurate results at a fast pace.

Physical Requirements (if applicable):

• Domestic and International travel up to 10%.

Additional Information:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

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!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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