Sr. Quality Systems Specialist (Hybrid)

Insulet Corporation-posted 4 months ago

$89,775 - $134,662/Yr

Full-time • Mid Level

Hybrid • Acton, MA

Miscellaneous Manufacturing

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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.

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

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

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

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