Insulet Corporation · 2 months ago
Director, Quality Operations (Onsite - Acton, MA)
US - Massachusetts (Acton - Office)
Full-time
Onsite
Director/Executive
$168K/yr - $252K/yr
10+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Director, Quality Operations will manage product and process Quality, ensuring compliance with regulatory requirements and overseeing the entire manufacturing process at the Acton, MA factory.
Health CareMedicalMedical Device
Responsibilities
Leads a team of factory QE, QC, and QA Quality associates, ensuring performance, growth, and collaboration with key stakeholders. Responsible for all aspects of Factory Quality, from Incoming Inspection through Final Release
Establishes, maintains, and promotes a strategy for compliance with quality objectives
Ensures timely and accurate evaluations and investigations. Implements prompt actions as necessary to ensure product safety and efficacy based upon investigation results
Manages and ensures follow-up on activities related to Internal and External QMS Audits
Establishes, maintains, and promotes a culture of compliance and a keen focus on quality and customer requirements throughout the site organization
Ensures an effective site Corrective and Preventive Action system
Ensures an effective site Quality Planning system
Establishes and maintains a robust employee training process
Supports and ensures establishment of a robust Environmental Monitoring program, if applicable for site
Ensures product is not released for distribution until all Device Master Record requirements have been met
Responsible for establishing and maintaining effective and efficient statistically-based Quality Control processes, i,e, incoming, in-process, and finished product inspection and release
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site)
Partners with other key stakeholders globally to drive harmonization and improvement
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement
Qualification
Required
Bachelor's degree (preferably science or engineering discipline) required
10+ years of experience in Medical Device Quality Operations with several or more years at the Quality Manager level
Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, development and engineering
Significant knowledge and experience with designing and implementing QMS and production processes that meet the requirements of ISO 13485, 21 CFR 820, and MDR
Intermediate to advanced skill level of MS Word, Excel, Access, Auto Cad or equivalent
Ability to make risk based decisions in concert with others, and according to established QMS processes
Excellent communication skills and the ability to work collaboratively with cross-functional teams
Global mindset and ability to work effectively in a matrixed organization
Broad spectrum Quality experience, including Incoming Quality, Quality Assurance, Quality Control, Quality Engineering, Quality Systems
Strong analytical skills and the ability to interpret complex data
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