Insulet Corporation · 1 month ago
Sr Manager, Process Excellence (Hybrid - Acton, MA)
US - Massachusetts (Acton - Office)
Full-time
Hybrid
Senior Level, Lead/Staff
$135K/yr - $203K/yr
10+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Sr. Manager, Process Excellence will ensure quality system compliance within Production and Process Controls, partnering with process owners to implement improvements and manage related quality systems.
Health CareMedicalMedical Device
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
Qualification
Required
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
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
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
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.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase