Senior Auditor, Quality System Compliance & Audit (Hybrid - Acton, MA)

Insulet Corporation•San Diego, CA

47d•Hybrid

About The Position

We are seeking an experienced and detail-oriented Internal Quality Auditor to join our Quality Compliance & Audit team under the global Quality Systems organization. The ideal candidate will have 5-7 years of experience in Quality Assurance or Regulatory Affairs within the medical device industry and a strong background in auditing and compliance with international standards and regulations. Reporting to the Director of Quality Systems Compliance & Audit, the Senior Auditor supports and manages multiple quality system processes, including Internal/External Audit and Inspection, and Corrective and Preventive Action (CAPA).

Requirements

Bachelor's degree in a scientific, engineering, or related discipline.
5-7 years of experience in Quality Assurance or Regulatory Affairs in the medical device industry; equivalent combination of education and relevant experience may be considered.
In-depth working knowledge in the application of ISO 13485, 21 CFR 820, EU MDR 2017/745, and MDSAP.
Proven experience supporting and responding to FDA and Notified Body audits.
Strong understanding of CAPA processes and root cause analysis methodologies.
Strong attention to detail and ability to manage multiple high-priority projects simultaneously.
Excellent written and verbal communication skills.
Demonstrated ability to influence others and lead change initiatives.
High level of integrity, professionalism, and strategic/risk-based thinking.
ISO 13485 Qualified lead auditor
Effective written and verbal communication skills
Proactive approach to continuous improvement with a solution-based mindset
Interpersonal skills to promote and accomplish constructive solutions to problems
High level of attention to detail and accuracy in all aspects of daily activities
Team-oriented with the ability to build trust and work collaboratively across departments.
Analytical thinking and problem-solving skills to support issue identification, root cause analysis and CAPA development.
Commitment to continuous learning and professional development in quality and regulatory standards.
Working with various digital business platforms and eQMS tools (LMS, LIMS, PLM, ERP, etc.)

Nice To Haves

Certified Quality Auditor (CQA) or equivalent certification
Relevant 13485 training/certification from an organization recognized in industry
Advanced user skills in the M365 Office suite including Teams, and SharePoint
Experience with electronic QMS platforms
Familiarity with global regulatory requirements beyond the U.S. and EU
Experience with PLM tools such as Agile and/or Arena

Responsibilities

Plan, conduct, and report internal audits in accordance with Insulet requirements, applicable international regulations and standards including ISO 13485, 21 CFR Part 820, EU MDR 2017/745, and the MDSAP approach.
Evaluate the effectiveness of the Quality Management System (QMS) and identify areas for improvement.
Support external audits including FDA inspections, Notified Body audits, and other regulatory assessments with preparation, back-room support, and follow-up activities.
As applicable, act as CAPA owner, approve CAPA plans, and help ensure CAPA effectiveness.
Collaborate cross-functionally to ensure timely and effective CAPA.
Maintain audit schedules, records, and documentation in compliance with regulatory and company requirements.
Maintain audit process tools & resources including but not limited to Teams/SharePoint folder & file sharing organization & hierarchy, standard communication templates, and other related standard process tools.
Act as a change agent to promote a culture of quality, continuous improvement, and compliance.
Influence stakeholders across departments to drive quality initiatives and ensure audit readiness.
Communicate clearly and effectively, both verbally and in writing, to all levels of the organization internally and externally.
Demonstrated ability to communicate with clarity and confidence, including leading presentations and delivering effective training programs that drive understanding and engagement.
Partner with key stakeholders in the planning and execution of the internal audit process for all Insulet locations.
Identify and assist in the resolution of quality-related issues, especially those that impact the quality system processes.
Provide input and support in the design, development, and delivery of training programs to enhance organizational understanding of quality system requirements, audit preparedness, and regulatory compliance.
Support implementation of computer-based quality system platforms including creation of associated work instructions and facilitation of training.
Provide coaching, advice, and oversight of auditors in-training in support of the guest auditor program.
Review procedures to ensure compliance with applicable regulatory and corporate standards.
Perform additional duties as part of the Quality Systems team as required.