Director, Quality System Compliance and Audits (Hybrid - Acton, MA. or San Diego, CA.))

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 Director Quality System Compliance and Audit Provides strategic direction, management and execution for Quality Management System Compliance and Audit at Insulet.  Ensures all applicable QMS regulatory requirements and standards are incorporated into the Quality Manual and respective QMS Process Policies.  Directs internal audit program to assess Insulet’s QMS implementation and execution for compliance to all applicable regulatory requirements, standards and incorporated business processes.  Issues non-conformances as identified and assures adequacy of corrective actions.  Reports to Executive Leadership on status of compliance and the performance of the quality audit program.  Champion for culture of quality at Insulet. This is a Hybrid role in either Acton, MA. or San Diego, CA.

Responsibilities:

• Assess and monitor regulations and standards for applicability to Insulet Quality Management System and ensure incorporation into quality system policies.

• Partner with Quality System Group Process Owners to assure incorporation of respective policy requirements into respective Quality System Processes.

• Process Owner for Quality System Audit Process.

• Establish annual Internal Audit schedule to measure and assure comprehensive compliance to applicable quality system regulations, standards and incorporated business processes. 

• Conduct independent audits of quality and compliance systems within technically advanced manufacturing settings and supporting sites.

• Initiate and maintain relationships with regulatory agencies and/or industry/professional organizations to keep aware of trends and initiatives in quality assurance, compliance, and inspections.

• Partner with other Quality System Process Owners to assure common understanding of developing interpretations of cGxP.

• Provide leadership to the audit team, full or part-time auditors.  Recruit internal part-time auditors and obtain management commitment for participation.

• Establish auditor qualifications, provide training, assessment, and mentorship to Insulet auditors.

• Maintain a current global audit schedule and generate periodic metric reports suitable for viewing by and presentation to senior leadership.

• Develop audit plans to determine QMS conformance to applicable regulations and standards, incorporation of business requirement and execution of QMS to established procedure.

• Manage and approve the initiation, assignment, execution and closure of all audit findings and related response actions.

• As process owner of Quality Audits, drive continuous improvement of the audit process and function.

• Provide leadership for external audits and inspections, including pre-audit preparation, SME preparation, back room and front room management, and audit responses.

• Leads external audit and inspection non-conformance response activities.

• Performs other duties as required.

Minimum Requirements:

• BS degree, in an engineering/scientific/computer systems/ or quality management curriculum and/or equivalent combination of education and experience. Master’s degree preferred.

• Minimum of 12+ years’ relevant experience in Quality Systems, Engineering, and/or Operations within the Medical Device industry, with strong Quality Management Systems knowledge.

• Minimum 5 years’ managerial experience.  Experience with working with senior stakeholders in matrixed environment.

• Detailed knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485, and relevant quality system regulations and standards (EU MDR, CMDR, TGA, etc.).

• Minimum 5 years GMP/GDP Quality Assurance experience leading and conducting audits preferably with a Medical Device product space.

• 13485 Lead Auditor certification (or equivalent).

Preferred Skills and Competencies:

• Strong leadership and analytical skills with team-focused attitude.

• Self-starter with demonstrated ability to design, develop, and automate business processes.

• Excellent interpersonal, verbal and written communication skills.

• Comfortable in a fast-paced environment with minimal direction.

• Ability to organize and judge priorities.

• Ability to communicate and work effectively at multiple levels within the organization.

• Advanced PC skill, word processing, spreadsheet, and database skills.

• ASQ Certified Quality Manager (or equivalent).

Physical Requirements (if applicable):           

• Domestic and International travel up to 40%. 

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: