I

Insulet

Designs and manufactures tubeless insulin pumps

Director Quality Operations

Full-TimeUpdated on 10/15/2026Deadline 12/28/26
No salary listed
Expert
Bachelor's
Gelang Patah, Johor, Malaysia
In Person
Manufacturing Quality & TestValidation, Compliance & Quality Systems

About the job

Requirements
  • A bachelor's degree in Science, Engineering, or a related discipline is required.
  • A minimum of 12 years of experience in Medical Device Quality Operations, including at least 10 years in a Quality Manager or equivalent leadership role.
  • Demonstrated ability to make risk-based decisions in collaboration with others and in accordance with established Quality Management System processes.
  • Broad quality experience, including Incoming Quality, Quality Assurance, Quality Control, Quality Engineering, and Quality Systems.
  • Strong analytical skills with the ability to interpret complex data and drive effective decision-making.
  • Broad knowledge of manufacturing, product development, engineering processes, equipment, methodologies, and techniques.
  • Significant knowledge and experience designing, implementing, and maintaining Quality Management Systems and manufacturing processes that comply with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.
  • Intermediate to advanced proficiency in Microsoft Word, Excel, data analytics tools, Power BI, or equivalent software.
  • Ability to work on-site at the Insulet Malaysia manufacturing facility; the position is not eligible for remote or hybrid arrangements.
  • Travel is estimated at approximately 10% and may vary based on business needs.
Responsibilities
  • Manage site-level Quality System compliance, ensuring compliance with US FDA, ISO 13485, and other applicable country-specific regulatory requirements.
  • Perform the role of site Quality System Deputy Management Representative by ensuring processes needed for the Quality Management System are documented, reporting on its effectiveness and improvement needs to top management, and promoting awareness of applicable regulatory and QMS requirements throughout the organization.
  • Lead a team of Quality Engineers, Quality Control, and Quality Assurance associates, ensuring strong performance, professional development, and effective collaboration with key stakeholders; oversee Factory Quality from Incoming Inspection through Final Product Release.
  • Establish, maintain, and promote strategies to achieve quality objectives and ensure compliance with applicable quality and regulatory requirements.
  • Ensure timely and accurate evaluations and investigations, and implement appropriate actions to maintain product safety and effectiveness based on investigation outcomes.
  • Manage and ensure timely follow-up of activities related to internal and external Quality Management System audits.
  • Establish, maintain, and promote a culture of quality, compliance, and customer focus throughout the organization.
  • Ensure the effectiveness of the site's Corrective and Preventive Action system.
  • Ensure the effectiveness of the site's Quality Planning process.
  • Establish and maintain an employee training program.
  • Support the establishment and maintenance of an Environmental Monitoring Program.
  • Ensure products are not released for distribution until all Device Master Record requirements have been met.
  • Establish and maintain effective, efficient, statistically based Quality Control processes, including incoming, in-process, and finished product inspection and release.
  • Ensure company operations comply with applicable laws, regulations, standards, good business practices, documented company procedures, and occupational health, safety, and environmental regulations applicable to the site.
  • Partner with key global stakeholders to drive harmonization, standardization, and continuous improvement initiatives.
  • Engage in, promote, and participate in Environmental, Health, and Safety initiatives, with a focus on continuous improvement.
  • Serve as a member of the IMY Plant Leadership Team and partner with key site and global stakeholders.
  • Serve on the IMY Material Review Board Committee.
  • Act as the IMY Management Representative and serve as a key stakeholder during internal, external, and regulatory audits.
  • Serve on the IMY CAPA Change Review Board Committee.
  • Own and manage the budget for all IMY Quality Assurance Operations.
  • Align team objectives with broader organizational goals and objectives, and track progress against established targets.
  • Lead, develop, and mentor a team of quality professionals in a fast-paced environment.
Desired Qualifications
  • Experience in high-volume electromechanical device manufacturing is preferred.

About the company

Insulet develops and manufactures insulin delivery devices for people with diabetes, led by the Omnipod tubeless, waterproof insulin pump system. The pod is worn on the body to deliver insulin under the skin, and is controlled wirelessly by a personal diabetes manager; Omnipod 5 adds automated insulin delivery that adjusts dosing using CGM data. The key differences are a tubeless, tubing-free design and ongoing updates that integrate automated dosing with CGMs, supported by a global manufacturing and distribution network. The goal is to simplify diabetes management with easy-to-use, flexible insulin delivery and automated dosing that fit users’ daily lives.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Acton, Massachusetts

Founded

2000

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Simplify's Take

What believers are saying

  • Q2 2026 revenue reached $801.7 million, up 23.5% year over year.
  • International Omnipod growth guide rose to 30%-32% after Spain and broader uptake.
  • Massachusetts offered over $40 million incentives for a potential Acton expansion through 2032.

What critics are saying

  • March 12 and May 26, 2026 corrections exposed tubing defects and under-delivery risk.
  • U.S. Omnipod growth guide fell to 17%-19% after weak type 2 retention.
  • Massachusetts class action Hu v. Insulet centers on manufacturing controls; settlement pressure intensifies through 2027.

What makes Insulet unique

  • Omnipod 5 offers tubeless, waterproof AID; Spain launched July 6, 2026.
  • Abbott Libre 3 Plus integration broadens Omnipod compatibility across the UK and Europe.
  • Acton manufacturing plus U.S. headquarters keep engineering, production, and distribution tightly co-located.

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Benefits

Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

1%

1 year growth

1%

2 year growth

1%
Yahoo Finance
Oct 12th, 2026
Insulet launches Omnipod Discover in the US, already used by over 15,000 Omnipod 5 users

Insulet Corporation has released Omnipod Discover across the US. The web-based data platform turns Omnipod 5 insulin pump data into clear visuals and personalised insights for users, caregivers, and healthcare professionals. Users get weekly glucose and insulin delivery reports on their smartphones. Clinicians get a concise report that overlays an Ambulatory Glucose Profile with key pump settings and bolus events. More than 15,000 Omnipod 5 users and over 1,800 healthcare professionals used the platform during a limited US release. It is also available in Spain, Australia, Saudi Arabia, Qatar, Kuwait, the UAE, and Israel. In data presented in June, 32% of users saw a clinically meaningful increase of 3% or more in time in range.

Boston Real Estate Times
Sep 11th, 2026
Insulet weighs major Acton expansion as state offers $40M in incentives.

Insulet weighs major Acton expansion as state offers $40M in incentives. September 11, 2026 ACTON - Massachusetts is offering Insulet Corp. a record-setting package of tax incentives as the medical device company considers expanding its operations and workforce in Acton, according to reporting by the Boston Business Journal. The proposed package from the Massachusetts Life Sciences Center would provide Insulet with at least $40,000 in tax credits for each new job created, up to 1,000 net new permanent full-time positions through 2032. The potential incentives would total more than $40 million, making it the largest single-company package offered through the state's life sciences tax incentive program, the Business Journal reported. Insulet, which is headquartered in Acton and makes automated insulin delivery systems under its Omnipod brand, is evaluating additional space near its existing campus as it continues to grow. The company has more than 1,700 employees in Massachusetts and has added more than 200 positions in the state this year, according to the Business Journal. "As employee growth has increased the need for collaboration and on-site engagement, the company is actively evaluating additional space in the Acton area," Insulet spokesperson Joan Campion told the Business Journal. The company is considering taking over 35 Nagog Park, a property near its global headquarters and U.S. manufacturing facility at 100 Nagog Park. Insulet also leases space at 50 Nagog Park, which serves as a distribution center. According to documents reviewed by the Business Journal, Insulet is considering spending about $33 million to renovate 35 Nagog Park into Class A office space with capacity for roughly 500 to 530 employees. The company has also outlined an additional $11 million to $12 million investment at 100 Nagog Park to enhance its UPS capabilities and add approximately 250 seats. If both projects move forward, the company's seating capacity in Acton would more than double from its current level of about 650, according to the Business Journal. The potential expansion has received support from Acton officials. Town Meeting voters approved a tax increment financing agreement for the 6.54-acre property at 35 Nagog Park earlier this year. The agreement is intended to support redevelopment of the property, although final terms have not yet been completed. The state effort to retain Insulet began in earnest in late 2025 as company officials explored options for expanding its manufacturing footprint. According to public records obtained by the Business Journal, state officials worked with Insulet on potential sites and offered assistance with real estate, local governments, financing, tax incentives and workforce development under the code name "Project Maverick." Massachusetts officials have characterized the potential expansion as an opportunity to retain a growing medical device company and create hundreds of additional jobs. Gov. Maura Healey told the Business Journal that the administration wants innovative companies to continue expanding in Massachusetts. "Massachusetts is where some of the world's most innovative companies are born, and we want them to build their future here too," Healey said, according to the Business Journal. "Insulet's expansion means hundreds of good jobs, new opportunities for our residents and continued investment in the communities that make our economy strong." Insulet has not yet made a final decision on its expansion plans. Campion told the Business Journal that the documents reflect preliminary planning and evaluation, including assessments of future operational and manufacturing needs. She said no definitive lease or purchase agreements have been executed and no final decisions have been made. Founded in 2000, Insulet has remained headquartered in Massachusetts as it has grown into a major medical device company. The company reported $2.7 billion in revenue in 2025 and had a global workforce of approximately 5,400, according to the Boston Business Journal. The potential expansion would build on an earlier expansion of Insulet's Acton operations. The company moved its global headquarters and U.S. manufacturing operations to 100 Nagog Park in 2019 following a redevelopment supported by a previous local tax incentive agreement. Acton Town Meeting approved the latest TIF proposal for 35 Nagog Park by a vote of 242 to 18, according to local records. The latest state incentive offer underscores the competition among states and communities to retain growing life sciences and advanced manufacturing companies and the jobs and investment they bring. This article is based on reporting by the Boston Business Journal. The Business Journal's full report was published Sept. 8, 2026, by reporter Hannah Baratham-Green.

The Diabetes Times
Sep 10th, 2026
Abbott's Libre established as the "most connected CGM in the world"

Abbott's Libre established as the "most connected CGM in the world" 10th September 2026 Abbott today announced the integration of its FreeStyle Libre 3 Plus sensor with Insulet's Omnipod(R) 5 Automated Insulin Delivery (AID) System in the UK, further expanding connected care options for people living with Type 1 diabetes who use a Libre sensor. The full UK availability of this latest integration builds on Abbott's FreeStyle Libre 3 Plus sensor and Tandem Diabetes Care's t:slim X2 insulin pump integration, which became available this summer. Based on the number of pump users having the ability to connect with Libre technology globally these latest partnerships establish Libre as the most connected continuous glucose monitoring (CGM) technology in the world*, providing users with access to more pump options globally than any other CGM. Today, in the UK, Abbott's connected diabetes management solutions are compatible with the following automated insulin delivery systems, or insulin pumps: * Insulet's Omnipod(R) 5 with both the FreeStyle Libre 3 Plus and the FreeStyle Libre 2 Plus sensors * Tandem Diabetes Care's t:slim X2 insulin pump with the FreeStyle Libre 3 Plus sensor * mylife Diabetes Care's YpsoPump insulin pump with the FreeStyle Libre 3 Plus sensor * MiniMed(TM) 780G system with the Instinct sensor, made exclusively by Abbott and distributed by Medtronic Hybrid closed loop systems like these combine a CGM with an insulin pump to automatically adjust insulin delivery based on glucose readings. They help people spend less time managing their condition and more time focusing on the things that matter to them. Libre technology provides real-time, personalised insights to help people understand how food, activity and medications affect their bodies. The latest Libre innovation is the world's first dual glucose-ketone sensor, which monitors glucose and helps detect rising ketone levels that can lead to diabetic ketoacidosis, a serious diabetes-related complication. Graeme Scott, 58, from Angus, who lives with type 1 diabetes said: "My life has changed immensely for the better since starting on a hybrid closed loop system. Having my sensor and pump working together gives me greater confidence and flexibility day-to-day, helping reduce the burden of managing diabetes. The technology means I spend less time thinking about my glucose levels and more time focusing on the things I enjoy. I'm running my own life instead of letting diabetes run it for me." Julia Hammac, General Manager for Abbott's diabetes care business in the UK, said: "For people living with type 1 diabetes, having access to technologies that work seamlessly together can make a meaningful difference to day-to-day diabetes management. By expanding our hybrid closed loop partnerships, we're giving people more choice in how they manage their condition and helping make advanced diabetes technologies more accessible through connected care solutions." Hilary Nathan, Director of Policy and Communications at Breakthrough T1D said: "For many people living with type 1 diabetes, technology is part of everyday life. Having choice really matters. Everyone's experience of diabetes is different, and what works brilliantly for one person may not be right for another. We welcome developments that give people more options and greater flexibility in how they manage their condition, allowing them to choose technology that fits their individual needs, preferences and lives. Ultimately, we want to see a technology landscape shaped around the people who use it, with the freedom to choose the tools that work best for them and today's announcement helps us take one step further towards that." *Data on File, Abbott Diabetes Care

Yahoo Finance
Sep 4th, 2026
Insulet beats Q2 estimates with $801.7M revenue, up 23.5% year on year

Insulet reported second-quarter revenues of $801.7 million, up 23.5% year on year and exceeding analyst expectations by 1.9%. The diabetes care company, which makes tubeless insulin delivery systems, posted the fastest revenue growth among four patient monitoring stocks tracked. However, Insulet's revenue guidance for the next quarter significantly missed analyst expectations. Despite beating earnings per share estimates, the market reacted negatively to the results. The stock has fallen 11.6% since the earnings announcement and currently trades at $147.50. The patient monitoring sector posted strong second-quarter results overall, with revenues beating consensus estimates by 1.4% across the group. Share prices for the four companies tracked have risen 2% on average since reporting earnings.

Yahoo Finance
Aug 26th, 2026
Insulet to Participate in Wells Fargo 21st Annual Healthcare Conference

Insulet to Participate in Wells Fargo 21st Annual Healthcare Conference Business Wire