Job Title: Senior Quality Systems Specialist

Department: Quality

FLSA Status: Exempt

Reporting to the Director of Quality Systems, the Senior 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 Senior Quality Systems Specialist owns and manages multiple quality system processes, including Corrective and Preventive Action (CAPA) and Internal/External Auditing.
Responsibilities:
• Assist in the development, implementation and maintenance of the quality system and its procedures
• Perform quality system monitoring and analysis, manage quality systems metrics dashboard, and publish management reports
• In conjunction with the Quality Systems Director, maintain QMS compliance to Medical Device Single Audit Program and ISO 13485
• Plan and execute the internal audit process for all Insulet locations
• Manage audits of the QMS by external parties, medical device certifying and regulatory agencies, such as US FDA and EU notified body
• 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.
• As quality process owner, help implement computer-based quality system platforms. Create associated work instructions and perform training.
• Oversee CAPA process, approve CAPA plans, and help ensure CAPA effectiveness
• Provide coaching and advice in CAPA excellence as necessary
• Suggest methods for and improve quality system effectiveness, with emphasis on preventive action
• Review procedures to ensure compliance with applicable regulatory and corporate standards
• Perform additional duties as part of the Quality Systems team as required

Education and Experience:
• 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
• Experience leading or supporting FDA QSIT, MDSAP, and ISO 13485 audits
• ISO 13485 Internal Auditor qualification and experience
• Experience with electronic QMS or PLM systems, such as Arena and Agile, preferred

Preferred Skills/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
• Advanced user skills in Microsoft Word, Excel, and PowerPoint
Job Type: Full-time
Travel: Minimal, up to 5%

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week. #LI-Hybrid

Additional Information:
The US base salary range for this full-time position is $89, 775.00 - $134, 662.50. 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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