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Sr Supplier Quality Systems Specialist (Hybrid - Acton, MA.)

Acton, United States

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling 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 who have insulin-requiring diabetes by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Supplier Quality Functional Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire people who are guided by shared values and a desire to exceed customer expectations. Our continued success depends on it.

Position Overview

Reporting to the Supplier Quality Systems Manager, the Sr Supplier Quality Systems Specialist - Functional Excellence is responsible for driving functional operational excellence within the Global Supplier Quality Engineering Team at Insulet.

The Sr Supplier Quality Systems Specialist will ensure supplier quality governance which includes creating best-in-class work instructions, procedures, and policies that define how Insulet selects, qualifies and manages supplier quality.
The role is responsible for developing and monitoring workflows and controls in PLM and ERP systems.
The Quality Systems Specialist is responsible for managing and maintaining the approved supplier list, tracking supplier history records, and overseeing related documentation to ensure compliance with quality system requirements.
The role ensures current products and new projects meet regulatory and quality
requirements for medical devices.
This position collaborates cross-functionally with departments such as Senior Management, Operations, IT, Engineering, Procurement, New Business Development, and Regulatory Affairs, as well as with external suppliers, contractors, and partners. The role focuses on driving supplier quality initiatives, supporting quality management systems, and contributing to both new product development and ongoing product support.
This role is accountable for leading internal and external audits, ensuring the organization maintains a state of continuous audit readiness. This includes proactively identifying and mitigating compliance risks, maintaining robust documentation practices, and fostering a culture of quality across supplier engagements. The Senior Quality Systems Specialist will also ensure that audit findings are addressed effectively and that quality system standards are consistently upheld.
Facilitate the development of meaningful, actionable KPIs aligned with key supplier quality imperatives. Lead monthly global supplier quality operational reviews to assess performance against these KPIs, document outcomes, and ensure timely tracking and closure of resulting actions

Responsibilities

Drive process improvements across global supplier quality operations to enhance efficiency and standardization across sites.
Develop, revise, and maintain Global Supplier Quality System documentation.
Partner with site and global teams to design and deliver training on quality system procedures.
Review and approve Quality Management System documents, protocols, and reports, ensuring compliance with ISO 13485 and 21 CFR Part 820.
Lead QMS remediation initiatives to address gaps and eliminate system-wide risks.
Manage core supplier quality processes including SCARs, EQARs, Supplier Evaluations, Continuing Assessments, Supplier Audit scheduling and tracking, Component NCMRs etc.
Monitor supplier performance trends and metrics, report insights and drive action.
Oversee the site-level Approved Supplier List and guide global teams on ASL governance and monitoring.
Maintain supplier quality records within ERP and PLM systems; support workflow development and optimization.
Collaborate with Supplier Commodity teams to achieve functional objectives and KPI targets.
Lead and support internal and external audits; drive timely and effective corrective actions.
Facilitate monthly SCAR review board to drive timeliness, effectiveness and adequacy and completeness of SCARs.
Support risk management activities and ensure alignment with applicable standards and regulations.
Facilitate the development of meaningful KPIs for supplier quality initiatives; lead global operational reviews to assess performance, document outcomes, and track actions to closure.
Perform other relevant duties as assigned to support the Supplier Quality function, with a focus on Quality Management System compliance and process-driven initiatives

Required Skills and Competencies

Strong interpersonal and communication skills, with the ability to engage, influence, and build trust across all levels of the organization and with external partners.
Confident and articulate presenter, capable of delivering clear, compelling messages in meetings, reviews, and cross-functional forums.
Proactive and vocal contributor, unafraid to challenge the status quo and advocate for quality-driven decisions.
Extroverted and collaborative mindset, with a natural ability to lead discussions, facilitate alignment, and drive consensus.
Skilled in stakeholder management, with a proven ability to navigate complex organizational dynamics and influence without authority.
Comfortable operating in a global, fast-paced environment, balancing strategic thinking with hands-on execution.

Education and Experience

BS degree in scientific discipline or quality systems, preferred
Minimum of 3-5 years’ experience in Quality Systems within the medical device industry, with exposure to Purchasing Controls
Demonstrated knowledge of PPAPs. Experience with the application of 21CFR820, ISO 13485.
Experience leading or supporting FDA QSIT, MDSAP, and ISO 13485 audits
Experience with electronic QMS or PLM systems, such as Arena and Agile, preferred

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

Additional Information:

The US base salary range for this full-time position is $89,850.00 - $134,775.00. 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.

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. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

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!

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.

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