What are the responsibilities and job description for the Manager, Field Quality position at Omnicell?
Do you want to make a meaningful difference in the quality of healthcare? Omnicell is empowering health systems and pharmacies to radically transform the way they manage medications, so they can achieve the vision of the Autonomous Pharmacy. Thousands of hospitals, pharmacies, skilled nursing facilities and care homes trust Omnicell to provide continuous innovation. They need us to deliver solutions to meet the ever-evolving challenges of the healthcare landscape. We encourage creative problem solving and outside-the-box thinking that only a diverse, well-rounded workforce can bring.
Join us as we build on our powerful combination of advanced automation, predictive intelligence, and expert services to create a safer future for patients—one where medication errors are a thing of the past. You’ll be joining an organization whose culture encourages individual development, rewards intellectual curiosity, and embraces an inclusive environment. Join our growing company and help shape the future at Omnicell!
Manager, Field Quality
Omnicell is excited to be seeking an experienced Quality Engineer for our Manager, Field Quality opening. This role will report to the Senior Manager, Field Quality and be responsible for leading Field Quality activities in collaboration with cross-functional personnel. Located in Cranberry Twp., PA or remotely in the US.
Responsibilities:
- Coordinate field quality projects utilizing quality tools to objectively clarify problem statements and create clear action plans, providing a coordinated effort on resolution.
- Support functional teams in development and continuous improvement efforts related to customer facing QMS processes and procedures from customer evaluation and acquisition through to end of service support.
- Ensure processes and procedures provide a common framework for roles and responsibilities, quality checks, and corrective action requirements.
- Work with the Customer experience teams and other functional areas on process validation and organizational readiness activities.
- Manage Field Quality Investigations and process. Drive a team in completing Field Quality Investigations and approving.
- Provide support to Professional and Technical Service to maintain required processes ensuring compliance to medical device regulations where required.
- Maintain a team that has expertise in our process for how we receive orders, deliver, install, implement, service, train on, invoice, and maintain our products and solutions for our customers
- Provide resources that conduct on-site audits of installation, implementation and service activities.
- Maintain, track and trend field quality data including out of box quality issues
- Ensure service records and customer feedback is effectively captured and routed via our QMS processes.
- Develop and Communicate metrics on the effectiveness of the customer facing QMS processes
Additional Responsibilities:
- 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
- Lead or Participate in Quality Management Review meetings
Required Knowledge and Skills:
- Ability to effectively interface and communicate with multiple constituents, including senior management, customers, consultants, vendors, and employees of all level
- Ability to work collaboratively with peers and team members
- Change agent who accepts and supports new ideas and processes
- Strongly demonstrated written and verbal communication 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 attention to detail
- Commitment to cost reduction/controls
- Strongly demonstrated organizational and project management skills
- Demonstrated proficiency with common MS office programs (Word, Excel, PowerPoint, Project)
- Ability to work under tight deadlines and handle multiple detail-oriented projects
- Self-starter, organized, analytical and decisive
- Team oriented with strong communication and mentoring skills
Basic Qualifications:
- Bachelor of Science degree Minimum (6) years quality/regulatory experience OR Master degree Minimum (4) years quality/regulatory experience
- Experience in product and process development
- Minimum four (4) years in an ISO 13485 and 9001 regulated environment
- Experience working with complex electro-mechanical systems
- Team Leadership experience
Preferred Qualifications:
- Direct Supervisory experience
- Proficiency in Risk management
- FDA regulated medical device experience
Work Conditions:
- Office Environment
- May travel up to 25%
To protect our employees, partners, and customers, Omnicell requires most U.S. employees to either be fully vaccinated for COVID-19 or obtain approval from Omnicell for an exemption and accommodation for a medical condition or a sincerely-held religious belief or practice
#LI-LS1
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.