Quality Assurance Specialist

Job Description

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 direction of the Quality Assurance Manager; the Quality Assurance Specialist is responsible for acting as a subject matter expert; providing guidance and direction within the Epocal quality system to ensure compliance with ISO13485, FDA Quality System Regulation and other regulations/standards as required.

Duties and Responsibilities

  • Supports management of specific quality systems: Management Review Process, Corrective and Preventive Action System, Quality Incident System, Calibration, Final Product Release, Planned Deviation Process, Internal Audit Program, Supplier Management etc...
  • Acts as QA approver for designated subsystems as delegated by manager
  • Maintains and improves quality system documentation, i.e. policies and procedures to ensure ongoing compliance with quality system standards and requirements as well as current company and industry practices.
  • Maintains quality systems that assure product conformance and customer satisfaction
  • Leads and/or supports Quality System initiatives and improvements
  • Facilitates and implements changes and improvements to the quality system to ensure the effective and efficient operation of the quality system
  • Develops training materials and conducts quality system training
  • Collects and analyzes data from quality processes and generates regular reports/metrics.
  • Leads, coordinates and conducts quality system audits, as required
  • Supports operations and R&D by providing guidance on actions required

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.

Key Contacts

  • Reports directly to the Quality Assurance Manager
  • Regular interaction across all departments
  • Interaction with all levels of operations and some key customers/suppliers

Job Demands

  • Strict attention to detail
  • Juggling and prioritizing multiple tasks within a dynamic work environment
  • Scaling of the quality system to suit a rapidly growing company
  • Ability to reconcile conflicting departmental priorities and obstacles to change
  • Able to mentor and guide other departments ensuring compliance while meeting business objectives
  • Proven ability to manage projects, achieve timelines and stay within budget
  • Process orientated, logical, meticulous, highly organized, and able to analyze data and implement solutions
  • Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time
  • Adaptable and willing to take on multiple new tasks and responsibilities
  • Ability to work effectively within a team environment while satisfying individual responsibilities
  • Ability to challenge system/processes and adapt them for the future
  • Effective oral and written communications skills
  • Physical
    • 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
  • 4+ years’ industry experience with a minimum of 3 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: Experienced Professional

Job Type: Full-time

Siemens is committed to creating a diverse environment and is proud to be an equal opportunity employer. Upon request, Siemens Canada will provide reasonable accommodation for disabilities to support participation of candidates in all aspects of the recruitment process. All qualified applicants will receive consideration for employment.

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