Sr Manager, Process Excellence (Hybrid - Acton, MA)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives using 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! This Sr. Quality Manager is responsible for ensuring quality system compliance within the Production and Process sub-process for governance and governance of related quality systems. The Sr. Quality Manager. Process Excellence will partner with “process owners” to identify best practices, harmonize where appropriate (and where not to) and implement improvements to be documented into Policies, Procedures, and Work instructions that define how Insulet manages the supply chain within “Production and Process Controls” to include: 

• Work Environments

• Calibration and Equipment Controls

• Microbiology and Sterilization

• Process Controls

• Process Validation

• Acceptance Activities

• Identification and Traceability

• Product Storage

• Handling, & Distribution Controls

• Servicing

This effort requires a broad skill set for facilitation, communication, and understanding of various Int’l regulations and standards to improve the quality management system. Effectively communicating quality system, requirements, optimizing development. Also,  review and ensuring ambiguities and conflicting requirements are resolved is critical to the success of
the position.

Responsibilities
• Create and update quality system and related quality system documents.
• Develop and work w/ Training department to deploy training for these documents.
• Review and approve Quality Management System documents
• Supporting remediation activities as needed.
• Support the development of workflows in these systems.
• Support resolution of issues with nonconformances in various processes

• Support internal and external quality system audits and related Root Cause Analysis, CAPA, and implementation activities.

• Champion global collaboration and innovation
• Review and approve new product documentation, as required.
• Support Risk Management activities and ensure compliance to standards and regulations.

Education And Experience minimum requirements:
• BS degree, in an Mechanical, Biomedical, engineering/life sciences curriculum,  or quality management curriculum or equivalent experience.
• A minimum of 10+ years’ work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and global experience.
•A minimum of 5 years in a leadership role in Quality Assurance or continuous improvement position within an FDA, ISO, or other regulated environment

•Experience in the development and implementation of effective Production and Process Control system 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.
• Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Visio, PowerPoint),

• Ability to effectively communicate with all levels of employees from front line operators up to and including 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.
• Familiarity with FDA, ISO, and other international regulatory requirements.
• Experience collaborating and communicating with individuals in multiple departments and at multiple levels in an organization.

• Previous experience in a management position a plus but not required

Preferred Skills and Competencies
• Auditor training certification to ISO 13485, 17025 or other industry QMS Standard
• CQE, CQM, CQA, Greenbelt or above, and / or PMP certifications a plus
• Strong verbal and written communication skills.
• Process Mapping

• Ability to organize and judge priorities.
• Able to work effectively in a high-stress, high-energy environment.
Physical Requirements
• Travel as required to support business needs, up to 25%

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $135,225.00 - $202,837.50 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.