Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our team as a Quality Assurance Specialist. Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Our impact: 70% of critical clinical decisions are influenced by the type of technology we provide. More than 31 million Canadians benefit from Siemens Healthineers products every year. An average of 85,000 Canadians per day receive treatment or tests from a Siemens Healthineers device. Siemens Healthineers participates in 30 healthcare research collaborations in Canada and around the world. https://www.healthcare.siemens.ca/healthcare-company-profile/about The Quality Assurance Specialist is based on site in Ottawa, ON. Siemens Healthineers Ottawa (SHS Ottawa) 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. The Quality Assurance Specialist requires a high level of attention to detail, as they are responsible for strictly adhering to the organization's quality assurance policies and supporting the management of specific quality subsystems (CAPA, Nonconformances, Audits, Change Control, Management Review). This is a role well suited to a process-orientated individual who is logical, meticulous, highly organized, able to analyze data and implement solutions. As the Quality Assurance Specialist, your responsibilities will include: Reviewing and approving Quality System records Maintaining and improving Quality System documentation Leading and/or supporting Quality System initiatives and improvements Developing training materials and conduct Quality System training Collecting and analyzing data and from quality processes and generating regular reports / metrics Leading, coordinating and conducting Quality System audits Supporting operations and R&D by providing guidance Prioritizing multiple tasks within a dynamic work environment As a successful Quality Assurance Specialist you will have: University Degree (preferably BSc or Engineering) and/or formal training in QA and/or an equivalent combination of education and experience acceptable to Epocal. 5 – 10 years of industry experience in operations, R&D or QA within an ISO registered manufacturing environment 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. Proven ability to manage projects, achieve timelines and stay within budget Ability to work effectively within a team environment while satisfying individual responsibilities Ability to challenge system/processes and adapt them for the future Possess effective oral and written communications skills We are looking for dedicated and talented people who tackle ever-changing challenges, customer needs, and questions from colleagues with clever concepts and creativity. We embrace change and work with curious minds re-inventing the future of work. Join us and let us focus together on what’s truly important: making lives better with new ideas and the latest technologies around the world. In our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity, Siemens Healthineers requires employees, contractors, and business partners to be fully vaccinated with relevant dose(s) of a Health Canada approved vaccine for all new hires by their start date. “Fully vaccinated” means it has been 14 days after receiving the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (i.e. two doses of a two-dose vaccine series, or one dose of a single-dose vaccine series), and which may include, at the Company’s discretion, any further doses in accordance with Health Canada guidelines. will only be granted for medical reasons or on the basis of a protected ground under applicable human rights legislation. Organization: Siemens Healthineers Company: EPOCAL INC. Experience Level: Experienced Professional Full / Part time: 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. By submitting personal information to Siemens Canada Limited or its affiliates, service providers and agents, you consent to our collection, use and disclosure of such information for the purposes described in our Privacy Code available at www.siemens.ca. Siemens s’engage à créer un environnement diversifié et est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Sur demande, Siemens Canada prendra des mesures d’accommodement raisonnables pour les personnes handicapées, dans le but de soutenir la participation des candidats dans tous les aspects du processus de recrutement. Tous les candidats qualifiés seront pris en considération pour ce poste. En transmettant des renseignements personnels à Siemens Canada limitée ou à ses sociétés affiliées, à ses fournisseurs de services ou à ses agents, vous nous autorisez à recueillir, à utiliser et à divulguer ces renseignements aux fins prévues dans notre Code de protection de la confidentialité, que vous pouvez consulter au www.siemens.ca.