Location: all cities,MA, USA
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology thatis 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!
Sr. Quality System Specialist (On-Site or Hybrid)
Hybrid, Full-time, Mid-Senior level
About the job
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and
healthier lives through the use of 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 Systems Specialist is responsible for ensuring supplier quality governance and governance of
related quality systems. The Sr. Quality Systems Specialist creates work instructions, procedures, and policies
that define how Insulet qualifies and manages supplier quality. The role supports and manages the
development of workflows and controls in PLM and ERP systems. The Sr. Specialist maintains the approved
supplier list, supplier history records, and other related documents in accordance with quality system
requirements. The role ensures current products and new projects meet regulatory and quality
requirements for medical devices. The Sr. Quality Systems Specialist interfaces with other Insulet
departments (e.g., Sr. Management, Operations, Information Technology, Engineering, Purchasing, New
Business Development and Regulatory Affairs) as well as suppliers, contractors, and other external parties on
issues related to supplier quality, quality management systems, materials, product development, and existing
product support. The Sr. Specialist supports internal and external quality systems audits that demonstrate
quality management system and regulatory standards are met. Effectively communicating quality system
requirements, optimizing development, review and/or approval of material and component documents and
protocols, and ensuring ambiguities and conflicting requirements are resolved are critical to the success of
the position.
Responsibilities
* Create and update supplier quality system and related quality system documents.
* Develop and deploy training for these documents.
* Review and approve Quality Management System documents and protocols.
* Ensure company compliance with these policies, procedures, and work instructions.
* Track trends in department and supplier performance via scorecards (e.g., CAPA completion, audit
completion, certifications maintained, FMEAs and quality agreements current) and report as needed.
* Supporting remediation activities as needed.
* Maintain supplier quality records in ERP and PLM databases.
* Support the development of workflows in these systems.
* Support resolution of issues with nonconformances in supplied parts and services.
* Support internal and external quality system audits and related RCA, CAPA, and implementation
activities.
* Review and approve new product documentation, as required.
* Review and approve Material and Component documents and protocols.
* Support Risk Management activities and ensure compliance to standards and regulations.
* Performs other duties as assigned.
Education And Experience
Minimum Requirements:
* BS degree, in an engineering/scientific/computer system/ or quality management curriculum or equivalent experience.
* A minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
* Experience in the development and implementation of effective Supplier Quality Control Systems.
* 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, Access, PowerPoint), ERP and PLM software.
* Demonstrated experience organizing and maintaining large documentation sets.
* Ability to follow up with task owners to 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.
Preferred Skills and Competencies
* Auditor training certification to ISO 13485, 17025 or other industry QMS Standard
* Working knowledge of EN 60601, Safety requirements for medical electrical systems.
* Working knowledge of ISO 62304, Medical Device Software - Software Life Cycle Process
* CQE and / or CQA certification
* Six Sigma/Lean certification
* Strong verbal and written communication skills.
* Ability to organize and judge priorities.
* Ability to generate and maintain accurate records.
* Skilled in Power BI or other visualization / business analytics software.
* Able to work effectively in a high-stress, high-energy environment.
Physical Requirements
* Travel as required to support business needs
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $85,400.00 - $128,300.00. 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.
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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