Engineer IV, Quality and Regulatory

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!

Quality and Regulatory Engineer IV

The role will execute the Quality function at the Omnicell Irlam facility. The role will ensure implementation and adoption of the Global QMS at the Irlam facility and will perform support functions for the Field organization in relation to install, service, and reverse logistics.

Responsibilities

  • Primary representative for the Global Quality team at the Irlam facility
  • Provide guidance and training to Irlam employees on the Global QMS and support adoption of the Global QMS
  • Assist in the establishment, maintenance and execution of quality acceptance criteria and activities including but not limited to incoming, in-process and final inspection
  • Manage Irlam Material Review Board and coordinate with Production Quality teams
  • Track Quality Metrics as appropriate for the Irlam facility.
  • Ensure that processes and procedures are properly documented, managed, implemented, and monitored.
  • Coordinates and documents roles and responsibilities between functional areas and processes
  • Ensure customer feedback including that from distributors is recorded, reviewed and acted on per QMS processes.
  • Leads root cause analysis into field related issues and ensures routing of identified issue into other functional areas such as product development and manufacturing/logistics
  • Coaches and mentors on quality problem solving tools
  • Collaborates with data analytics and Operations teams to define value-add metrics with thresholds that drive Corrections and Corrective Actions via our Global QMS.
  • Support QMS audits at the Irlam facility

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
  • 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)
  • Demonstrated success in applying quality problem solving methods such as fishbone diagrams, FMEA, process capability analysis, 8D methodologies, CAPA, DoE, SPC, etc.
  • Ability to work under tight deadlines and handle multiple detail-oriented projects
  • Self-starter, organized, analytical and decisive

Basic Qualifications

  • Engineering or science degree
  • Minimum of 6 years of related experience
  • Experience implementing and managing either ISO 9001 or ISO 13485 QMS system
  • Proficient computer skills using Microsoft Office Suite

Preferred Knowledge and Skills

  • Quality management within a high tech manufacturing environment with medical products, which include Hardware and Software complexities.
  • Competence in using ERP, CRM, and PLM systems (SAP, Siebel, and Agile PLM experience a plus).
  • Internal Audit certification
  • Experience in working within a warehouse and production line environment.

Work Conditions

  • Office / Production / Warehouse primarily.
  • Occasional travel to the USA, travel throughout EU (15%)

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.

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