Epocal is a leading manufacturer in the clinical Point Of Care (POC) diagnostic product market. The epoc© Blood Analysis System is healthcare’s first cost-effective POC testing solution to leverage Smartcard Technology and wireless communication to provide caregivers with real-time, lab-quality blood gas, electrolyte, and metabolite results at the patient bedside. This system is now a well-established tool of the medical profession available worldwide.
Epocal is committed to delivering high-quality products and services that patients and providers can rely on for consistently accurate and actionable information. We deploy unique innovative technologies that not only transform diagnostic products, but also expand into new platforms and solutions with proven health and economic outcomes.
In this role, under the direction of the Quality Assurance Manager, the Quality Assurance Specialist is responsible for:
Duties and Responsibilities
· Support and management of Quality System processes: Management Review, CAPA, Nonconformance, Calibration, Final Product Release, Planned Deviation, Internal Audit, Supplier Management, etc...
· Maintenance of Quality System documentation to ensure ongoing compliance with standards and regulations as well as current company and industry practices.
· Development and implementation of Quality System training material
· Collection and analysis of data from quality processes for regular reports and metrics
· Coordination and/or support of internal Quality System audits as required
· Support of Operations and R&D departments as required
Duties are not limited to those listed above. Additional duties may be assigned as required. However, reasonable accommodations will be made if all possible under business conditions.
· Reports directly to the Quality Assurance Manager
· Regular interaction across all departments
· Interaction with all levels of operations and some key customers/suppliers
· Strict attention to detail and ability to manage multiple tasks within a dynamic work environment
· Able to mentor and guide personnel in other departments to ensure compliance
· Able to work independently and collaboratively, and willing to take on new tasks and responsibilities
· Able to challenge systems and processes and adapt them for future requirements
· Able to communicate effectively in both oral and written formats
· Physically able to work for extended periods of sitting/computer use
Skills & Qualifications (Education and Experience)
· University Degree (preferably BSc or Engineering) and/or formal training in QA and/or an equivalent combination of education and experience acceptable to Epocal
· Four or more years industry experience with a minimum of three years or more in an ISO registered manufacturing environment, and/or an equivalent combination of education and experience acceptable to Epocal
· ISO13485 and FDA Quality System Regulation (QSR) experience preferred
· ASQ certified designation: Certified Quality Auditor (CQA), Certified Quality Manager (CQM) or Certified Quality Engineer (CQE) preferred
· High level of computer literacy including MS Office (i.e. Word, Excel, PowerPoint) SharePoint, Flowcharting software, Acrobat, etc.
Organization: Siemens Healthineers
Company: EPOCAL INC.
Experience Level: Mid-level Professional
Job Type: Full-Time temporary
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