The Quality Assurance Auditor will plan, execute, and report on quality management system internal audits, ensuring performance to Omnicell quality standards and regulatory requirements within our manufacturing/production facilities.
Establish internal audit schedule, and execute audits of the quality management system in accordance to the schedule
Develop and communicate results of internal audit activities
Collaborate with peers to develop solutions to gaps found in internal audits
Support the Quality Department objectives and goals by managing or participating in Quality projects
Manage and/or participate in CAPAs as required
Act as a liaison between Quality and other Omnicell functional departments
Participate in Quality Management Review meetings
Mentor internal audit staff members
Travel up to 20%
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Omnicell will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
Required Knowledge and Skills:
Demonstrated ability to effectively interface and communicate with multiple constituents
Change agent who accepts and supports new ideas and processes
Strong written, verbal and presentation skills to all levels of an organization
Refined multi-tasking and time management skills
Ability to consistently balance sense of urgency with diplomacy/empathy
Ability to make decisions and execute directives
Strongly demonstrated organizational and project management skills with strong attention to detail
Ability to work under tight deadlines and handle multiple detail-oriented projects
Proficient with MS office programs (Word, Excel, PowerPoint, Project)
Team builder, self-starter, organized, analytical and decisive
Two (2) years’ experience working within a regulated environment (i.e. ISO or FDA)
Experience auditing a Quality Management System within a manufacturing/production environment
Internal Number: 9333
Since 1992, Omnicell has been a leader in medication and supply dispensing automation, central pharmacy automation, IV robotics, analytics software, and medication adherence and packaging systems, Our employees are inspired to create safer and more efficient ways to manage medications and supplies across all care settings —from the acute care hospital setting, to post-acute skilled nursing and long-term care facilities, to the patient’s home. Over 4,000 customers worldwide use Omnicell® automation and analytics solutions to increase operational efficiency, reduce medication errors, deliver actionable intelligence and improve patient safety, with more than 32,000 institutional and retail pharmacies working with Omnicell to maintain high accuracy and quality standards in medication dispensing. Omnicell – Inspired by Care.