Director, Quality Systems (Hybrid) at Insulet in Acton, Massachusetts

Job Description:

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!

As the Director of Quality Systems, you will provide strategic direction and management of Insulet Corporation's Quality System and Quality Systems team, including sustaining and improvement activities. You will establish workflows for computer-based Quality Management System (eQMS) platforms. Overse administration of the Management Review, Quality Planning, Non-Conformance, Corrective and Preventive Action (CAPA) and other supporting processes. Additionally, you will Interface with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Quality and Regulatory Affairs) as well as with suppliers, partners, customers and other external parties on issues related to quality.

Responsibilities:

• Ensure the Insulet Global Quality System is compliant to all applicable global regulatory requirements and standards.


• Create and/ or improve quality systems to ensure best practices are utilized. Perform assessments, write and execute project plans, manage change.


• Design and establish workflows for computer-based Quality System platforms. Review and approve User and Functional Requirement Specifications, Quality Plans, Validation Protocols, and Reports. Implement associated work instructions and perform training.


• Provide oversight of Global CAPA process, chair Global CAPA Review Board, approve CAPA phases for Global CAPAs, and ensure overall CAPA system effectiveness.


• Measure and evaluate quality system effectiveness with emphasis on preventive action. Suggest methods for improving product quality, documentation, or quality system processes.


• Provide guidance and direction for Quality System implementation at Insulet Corporation business units and sites.


• Perform Quality System monitoring and analysis activities and publish management reports.


• Execute the Management Review Process.


• Represent the Quality Systems department at meetings and on project teams.


• Provide direction and management of staff of Quality System Managers, Quality System Engineers and Quality System Specialists.


• Performs other duties as required.

Education and Experience:

Minimum Requirements:

• BS degree, in an engineering/scientific/computer systems/ or quality management curriculum and/or equivalent combination of education and experience. Master's degree preferred.


• Minimum of 12+ years' relevant experience in Quality Systems, Engineering, and/or Operations within the Medical Device industry.


• Minimum 5 years' managerial experience.


• Detailed knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485, and relevant quality system regulations and standards (EU MDR, CMDR, TGA, etc.).


• Significant knowledge of Root Cause Analysis / Problem Solving methods.


• Experience with implementation and administration of quality workflows on computer-based Quality Management System (eQMS) platforms including Management Review, Quality Planning, Non-Conformance, Corrective and Preventive Action (CAPA) and other supporting processes or equivalent.


• Experience in the development and implementation of effective Quality Systems.


• Experience directing leaders and managing diverse teams.


• Experience leading improvement projects.

Preferred Skills and Competencies:

• Strong leadership and analytical skills with team-focused attitude.


• Self-starter with demonstrated ability to design, develop, and automate business processes.


• Excellent interpersonal, verbal and written communication skills.


• Comfortable in a fast-paced environment with minimal direction.


• Ability to organize and judge priorities.


• Ability to communicate and work effectively at multiple levels within the organization.


• Advanced PC skill, word processing, spreadsheet, and database skills.


• ASQ Certified Quality Manager (or equivalent).

Physical Requirements (if applicable):

• Domestic and/or International travel, up to 20% if Acton based and up to 40% travel if remote or other Insulet site based.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid

Additional Information:
The US base salary range for this full-time position is $156,000.00 - $234,450.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

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.

( Know Your Rights )