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.

The Quality Systems Specialist supports the ISO 13485-certified Quality Management System (QMS) at this fast-growing medical device company, assisting in the implementation, improvement and daily management of the QMS across Insulet. The Quality Systems Specialist helps manage multiple quality system processes, including Corrective and Preventive Action (CAPA), Non-Conforming product (NCMR) and Internal/External Auditing.

Responsibilities:

• Assist in the development, implementation and maintenance of the quality system and its procedures

• In conjunction with the CAPA process owner, assist in the CAPA process, approve CAPA plans, and help ensure CAPA effectiveness

• Provide coaching and advice in CAPA excellence as necessary

• Facilitate and guide CAPA teams through the CAPA process including root cause investigations, risk assessments, solution planning, implementation, and verification of effectiveness
• Perform quality system monitoring and analysis, support quality systems metrics dashboard, and publish management reports, as needed

• Identify and assist in the resolution of quality-related issues, especially those that impact the quality system processes
• Create and/or improve quality systems to ensure best practices are utilized. Perform assessments, write and execute quality plans, manage change.
• Suggest methods for and improve quality system effectiveness, with emphasis on preventive action
• Review procedures to ensure compliance with applicable regulatory and corporate standards

• In conjunction with the Quality Systems Director, maintain QMS compliance to Medical Device Single Audit Program and ISO 13485
• Perform additional duties as part of the Quality Systems team as required

Minimum Requirements:

• BS degree in scientific discipline or quality systems, preferred
• Minimum of 3 years’ experience in quality systems within the medical device industry
• Demonstrated knowledge of and experience with the application of 21CFR820 and ISO 13485

• Understanding of root cause analysis methodologies and tools (e.g. 5-Whys, Fishbone Diagram, FMEA)
• Experience with electronic QMS or PLM systems, such as Arena and Agile, preferred

• Ability to work independently and follow up with task owners to close out open items.
• Experience collaborating and communicating with individuals in multiple departments and at multiple levels in an organization.

Preferred Skills and Competencies:

• Strong commitment to the accomplishment of tasks
• Initiative to identify opportunities for improvements
• Interpersonal skills to promote and accomplish constructive solutions to problems
• Self-motivated, focused and persistent
• High level of attention to detail and accuracy
• Excellent organizational, problem-solving and communication skills
• Ability to prioritize work and handle multiple assignments, while maintaining quality
• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
• Ability to work effectively between multiple levels within the organization

• ISO 13485 Internal Auditor qualification and experience
• Advanced user skills in Microsoft Word, Excel, and PowerPoint

• Travel as required to support business needs, up to 10%

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 $69,800.00 - $104,900.00. 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.