Manager, Internal & External Audits

 Formed in 2000, Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than eighty countries around the world.  

 “Leading the World with Innovative Healthcare Solutions that Enhance Lives.”

 Summary:

The Manager, Internal/External Audits serves as the management representative within the organization and company’s certifications registrars. Responsible for managing the internal audit program and the external audits from planning, to scheduling, coordination, reviewing and reporting audits findings and reports, overseen the internal audit team, providing expertise in auditing standards and performance criteria related to the audits scope. 

Main Activities/Responsibilities:

• Develop and maintain a Certification/Qualification program for internal auditors. Maintain external auditor credentials within the QMS records. Lead the Internal Audit Team (IAT) monthly meetings and maintain associated records.
• Plan and conduct the internal audits of departments and functions against medical device regulations (21 CFR 820 and ISO 13485) and standards to achieve corporate compliance objectives. 
•  Prepare and maintain the Internal Audit Schedule, including assignment of auditors, status of audit/report/findings, report review, responses, and audit closure. 
•  Manage activities through the entire IAT lifecycle, from pre-meetings to opening meetings to closure. 
• Communicate with Management and Auditee(s) in accordance with the IAT [FC1] [OY2] [OY3] . Lead the Internal Audit Program and External Inspection Program.
• Lead preparations for internal audits, external audits, and regulatory inspections readiness.
• Onsite or remote virtual auditing (front room/back room) support and coordination including assigning roles and responsibilities to auditors, auditees, and scribes.
• Responsible for the completion audit findings responses for audits executed internally or externally to ensure proper corrective action were taken accordingly.
• Develops the organization’s yearly internal audit schedule.
• Serve as the lead auditor that manages audit assignments, reviews all paperwork and audit reports.
• Plans the audit work for assigned areas, including the creation of audit programs and the identification of the most efficient and effective audit techniques. Lead planning meetings with auditees to ensure proper communication of the audit approach.
• Review and approve the reports that were prepared by other auditors.
• Function as the key contact for the coordination of external audits and ensure good interactions with external auditors and law enforcement agencies. 
• Creates, and maintains supplier audit files.
• Liaises with business partners and auditors to obtain/provide supplier information and align scheduling of audits.
• Supports audit schedule change requests for new suppliers and other changes impacting the schedule as required.
• Develop the supplier audit calendar for North America and Asia. 
• Supports the Supplier Audit Manager(s) and supplier auditors as needed.
• Collects as required supplier audit metrics and communicates to Supplier Audit Manager(s).
• Participate in the development and implementation of policies by providing inputs based on the audits finding for continuous improvement purposes. Recommend or provide inputs that could help to enhance and improve process or procedures.
• Work with management to resolve issues that may have been identified through audit findings.
• Conduct follow-up on all the different audit assignments given to other auditors.
• Ensure proper documentation of the results of the audit evaluations.
• Strong people skills and the ability to work professionally with persons at all levels, and to maintain effective working relationships.
• Ability to communicate clearly and effectively in oral and written form.
• Perform other duties as assigned.

 Competencies:

• Computer proficient 
• Strong mindfulness
• Effective communication and collaboration skills
• Ability to interface with cross functional teams. 
• Ability to work under pressure with multiple deadlines.
• Proficient understanding of written and verbal English

 Reporting Relationships and Supervision:

• This position reports directly to VP Quality & Regulatory Affairs with no direct reports 

Education and Experience:

• Bachelor’s Degree in engineering or scientific discipline or equivalent experience
• 3 years of experience as a Lead Auditor with exposure to 3rd party audits.
• Current Lead Auditor certification for ISO 13485 and experience with Medical Device Single Audit Program (MDSAP) and ISO 14971 Risk Management for Medical Devices
• Working knowledge of international medical device regulatory requirements (EUMDR, Health Canada regulations, etc.), preferred