Job details
Salary $153,750 - $197,313 a year
Full job description
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 pharmacyThousands of hospitals, pharmacies, skilled nursing facilities and care homes trust omnicell to provide continuous innovationThey need us to deliver solutions to meet the ever-evolving challenges of the healthcare landscapeWe 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 pastYou’ll be joining an organization whose culture encourages individual development, rewards intellectual curiosity, and embraces an inclusive environmentJoin our growing company and help shape the future at omnicell!
Sr manager, medical safety & quality (remote)
Reporting to the sr director of global quality product and servicesThe sr manager, medical safety & quality will accurately and comprehensively characterize and maintain the risk profile of omnicell products, including identification of modes of injury to patients and users, assessment of maximal severity of the injury, and the likelihood of occurrence of harm, drawing upon clinical knowledge and research to support conclusionsThis is a us-based remote role.
Responsibilities:
Act as subject matter expert for product safety for patients and product users
Implement standard omnicell-wide process for identifying, quantifying, mitigating, and monitoring risks associated with omnicell products
Utilize clinical expertise and iso 14971 risk management guidance to formulate a clear rationale for risk acceptability
Demonstrate the ability to train and advise product teams on safety risks and methods of safety risk analysis
Supervise the execution of post-market product risk assessments for all products to ensure continued mitigation of identified hazards, determine the potential for harm to patients and device users
Contribute to the determination of medical device reportability of post-market events and incidents in global markets
Continually ensure the health benefits of a given product outweigh the defined risks of harm per the product’s risk management file
Provide medical expertise to the drafting of complete hazard and harm lists throughout the product lifecycleAssess potential severity and occurrence of harm
Review complaints flagged as potential safety events as a clinical expert
Serve as a clinical advisor for characterization of risks, preparation of risk files and supporting materials
Provide clinical evaluation that is compliant with product quality and regulatory requirements and intended to mitigate risk
Lead team of safety risk, quality engineers and analysts completing safety risk work as part of new product development and post-market activities
Ensure team is in compliance with regulatory requirements and deadlines for reporting medical device safety events and incidents
Participate in the field action process as a clinical expert to determine the action required or recommended based on safety and customer satisfaction risk
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
A 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 a sense of urgency with diplomacy/empathy
Ability to make decisions and execute directives
Strongly demonstrated attention to detail
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
Basic qualifications:
Licensed pharmacists or medical doctorate as recognized in the country were grantedExMd, do, mbbs or equivalent medical doctorate degree
7+ years’ work experience, which may include indirect or direct patient care (pharmacy, hospital, clinic, risk management in health care facility) or industry quality/regulatory medical device experience
Experience with fda and/or other regulatory audits/inspections
Team leadership experience
Experience serving as a recognized authority on pharmaceutical or device medical safety, able to assess device risk competently and thoroughly in terms of severity and likelihood of occurrence
Experience representing the clinical perspective to regulators and customers
Experience with regulations related to risk management
Preferred qualifications:
Direct supervisory experience
Proficiency in risk management
Previous medical device experience in the development of safe hardware and software products, including iso 9001/13485/14971, fda regulations 21cfr 820, eu mdr, iec 60601, iec 62304, and iec 62366.
Work conditions:
Office environment
May travel up to 10%
To protect our employees and those who spend time at our facilities, and as may be required by our customers, omnicell requires most u.sEmployees to be fully vaccinated for covid-19 or obtain an approved exemption from omnicell as an accommodation for a disability or sincerely held religious belief or practice.
Compensation will vary based on regionFor the state of colorado only, the expected pay is $153,750 to $197,313Benefits can be found on www.omnicellbenefits.com.
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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 applicantHowever, 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.
