Quality Engineer III, Internal Auditor
2 weeks ago
QMS Lead Internal Auditor (Quality Engineer III)Are you Quality professional who has experience in Internal Auditing for Quality Management Systems (QMS)? Are you looking for an exciting new opportunity? Then Omnicell has the perfect opportunity for you.This individual contributor role will report to the Director, Quality Assurance. Our QMS Lead Internal Auditor will be responsible for leading Omnicells Global QMS Audit program across multiple business units, collaborating with cross-functional personnel, and for establishing metrics to demonstrate the effectiveness of our QMS Internal Audit program.Responsibilities:Lead and Execute QMS Internal Audit activities for multiple business units.Work with business units to identify improvement opportunities.Facilitate External Audit activities with Notified Bodies for multiple business units.Establish best practices, drive process and quality improvements within the QMS Audit program.Demonstrate effectiveness of the QMS Internal Audit program to internal and external auditors and inspectors; will serve as a subject matter expert.Mentor other auditors within the QMS Internal Audit program.Establish quality metrics to demonstrate effectiveness of the QMS Internal Audit program.Additional Responsibilities:Support the Quality Department objectives and goals by managing or participating in Quality projectsManage and/or participate in CAPAs as requiredAct as a liaison between Quality and other Omnicell functional departmentsRequired Knowledge and Skills:Ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, vendors, and employees of all levelAbility to build relationships and work collaboratively with peers and team membersChange agent who creates, accepts and supports new ideas and processesStrong written and verbal communication; as well as effective presentation skills to all levels of the organizationRefined multi-tasking and time management skillsAbility to consistently balance sense of urgency with diplomacy/empathyAbility to make decisions and execute directivesStrong attention to detail, organization, and project management skillsAbility to work under tight deadlines and handle multiple detail-oriented projectsSelf-starter, organized, analytical and decisiveBasic Qualifications:Bachelor's degreeMinimum 3 years quality/regulatory experienceExperience in QMS internal auditingCertified Quality Auditor (CQA) or other audit training that certifies in auditing principlesPreferred Qualifications:ISO 13485 or FDA regulated medical device experienceWork Conditions:Office Environment Hybrid, as neededMinimal travel (10%)#J-18808-Ljbffr
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