Epocal, part of Siemens Healthineers, is a leading manufacturer of a clinical Point Of Care (POC) diagnostic product. 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.
Epocal was acquired by Siemens Healthineers in October 2017. As a leading medical technology company, Siemens Healthineers enables healthcare providers to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company's foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers' ability to provide high-quality, efficient care to patients.
For more than 100 years, Siemens Healthineers in Canada has helped healthcare providers achieve their goal of improving outcomes while reducing costs. From the Atlantic to Pacific oceans, more than 800 employees in Canada work together to deliver solutions for healthcare providers, resulting in 70% of medical decisions being influenced by the technologies we provide.
More information is available at: www.siemens-healthineers.ca
Under the supervision of the Associate Quality Assurance Specialist; the Quality Control Inspector is responsible for direct examination of incoming, in process, or final product to ensure that quality standards are aligned with existing specifications, procedures or requirements. This position requires a high level of attention to detail, as the Quality Control Inspector is responsible for strictly adhering to the organization's quality assurance policies and identifying defects and or production errors in order to prevent these materials from entering the supply chain.
Duties and Responsibilities
· Completes inspections of incoming materials and documents inspections using established procedures.
· Initiates and writes non-conformances (quality incidents) arising from incoming inspections or final release inspections.
· Reviews the Lot/Device History Records for finished products (cards, readers, hosts, EDM software and cap tubes etc..) for compliance to procedures and good documentation practices. Documents final approval for product release.
· Participates in the writing and updating of inspection procedures/SOP, protocols and checklists/forms.
· Supports coordination of the planned deviation process
· Evaluates problems and makes recommendations for possible corrective action to supervisor.
· Investigates material returns from assembly by performing additional inspections as required.
· Approves release of materials to the next step in the process.
· Reworks or rejects subassemblies or finished products as required.
· Conducts and documents process and system audits using written procedures as audit standards. Accurately documents the results of the inspections and testing.
· Maintains all controlled document files and test records in a timely and accurate manner.
· Coordinates the calibration program company-wide.
· Monitors critical equipment and instrumentation to ensure proper operation and calibration.
· Develops, reviews, and maintains metrics in relation to tasks assigned.
Note: 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 Associate Quality Specialist
· Regular interaction across all departments particularly with operations and materials management
· Attention to detail
· Flexibility to work overtime and on different shifts as required
· Ability to use technical equipment, such as microscopes and automated testing machines.
· Effectively adapts to tight deadlines, heavy workloads, and sudden or frequent changes in priority in order to accomplish objectives.
· Physical or muscular ability and dexterity must be at a level that allows the person to perform a variety of manual tasks where close adjustment is required and a high degree of whole body coordination is normally involved.
· Ability to lift, move, and manipulate items, boxes, containers of moderate weight (~20kg) on a routine basis
· Ability to work with, coordinate and integrate across a multidisciplinary team.
· Capable of influencing individuals for which the incumbent may have no direct authority to ensure attention and energy remains focused on bringing various activities together to meet timetable(s).
· Must exhibit tact and discretion in pointing out issues to operations. Good communication skills are important to motivate others to improve the quality of their work, as well as to explain findings clearly.
· Able to write technically.
· Stays motivated even when faced with inevitable delays, setbacks, policy shifts and disappointment.
Skills & Qualifications (Education and Experience)
· High School Diploma and/or an equivalent combination of education and technical experience acceptable to Epocal.
· 2 or more years of Quality Control experience in Receiving Inspection is preferred
· Proficient in QC/QA methods
· Driving license and access to automobile preferred
· Previous experience within a medical device or pharmaceutical environment is an asset
· Computer literate including MS Office (i.e. Word, Excel,) SharePoint, etc.
Organization: Siemens Healthineers
Company: EPOCAL INC.
Experience Level: Experienced Professional
Job Type: Full-time
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