Oct 11, 2022

Quality Manager

  • Sepset Biosciences Inc.
  • Remote (Victoria, BC, Canada)
Full time Product Development Quality Regulatory

Job Description

Sepset Biosciences Inc. seeks applications for an experienced quality assurance (QA) and regulatory affairs manager or consultant to help with the development and regulatory approval of Sepset’s medical diagnostic test for sepsis. The QA manager will report to the CSO and work closely with senior management and company employees to implement and maintain an eQMS system as well as ensure regulatory compliance. The individual will also make sure that company leadership is engaged in quality management practices and training to ensure that company objectives regarding quality and risk management are successfully met.

Qualifications and Experience

  • MSc or PhD in biomedical engineering or biomedical science (BSc with extensive medical device development and quality management experience may also be considered).
  • QA or regulatory affairs training an asset.
  • At least 4 years experience working in the medical device field.
  • Knowledge of medical diagnostic test technology, particularly quantitative polymerase chain reaction (qPCR) based assays and class II medical devices.
  • Demonstrated ability to generate documents (standard operating procedures, training, design history file, etc.) and maintain document control.
  • Experience with or knowledge of medical device regulations for both the US FDA and Health Canada.
  • Familiarity with the international standards that apply to medical device quality management and risk management (ISO 13485, ISO 14971, 21 CFR Part 11).
  • Ability to coordinate with in-house as well as contract organizations to meet project deadlines and ensure quality processes are maintained.
  • Experience working with electronic quality management software.
  • Excellent written and verbal communication skills.
  • Ability to work in a dynamic and fast-paced environment.
  • Proficient with use of computers and software (Microsoft Office, Google Docs, Zoom, Excel, PowerPoint, Adobe etc.).

Sepset Bioscience Inc. Offers

  • Competitive compensation 
  • Flexible work schedule
  • Collaborative and supportive work environment
  • Ability to work in person (office in Victoria, BC), virtually or hybrid arrangement
  • Excellent health and dental benefits
  • Opportunities for professional development and training

Sepset Biosciences Inc. (www.sepset.ca), a subsidiary of Asep Medical Holdings Inc. (asepmedical.com), is developing a novel diagnostic test for sepsis that examines a gene expression signature from patients that is predictive of severe sepsis. Sepsis is one of the most significant diseases contributing to antibiotic failure around the world and it is a serious medical condition that is responsible for nearly 20% of all deaths on the planet. The SepsetER test is a blood-based gene expression assay that is straightforward to implement, and results are obtained in about an hour in the emergency room or intensive care unit. This proprietary diagnostic technology differs from current diagnostic tests in enabling diagnosis of severe sepsis within 1-2 hours of first clinical presentation (i.e., in the emergency room), while other diagnostics only provide diagnosis after 24-36 hours. Sepset believes this will enable critical early decisions to be made by physicians regarding appropriate therapies and reduce overall morbidity and mortality due to sepsis. Sepset also has a second-generation test in development that assigns early stage patients to mechanistic and risk groupings, enabling the early application of precision medicine treatments.

Sepset recognizes the importance of equity and diversity. An open and diverse community fosters the inclusion of voices that have been underrepresented or discouraged. We encourage applications from members of groups that have been marginalized on any grounds enumerated under the B.C. Human Rights Code, including sex, sexual orientation, gender identity or expression, racialization, disability, political belief, religion, marital or family status, age, and/or status as a First Nation, Metis, Inuit, or Indigenous person.

All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority. Please send application packages (cover letter and resume) to careers@asepmedical.com. We appreciate interest from all applicants but only candidates considered for employment will be contacted.

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