Quality Manager (Software Validation Engineer)

SOPHiA GENETICS

Lausanne, CH
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 06/08/2021
  • Website: sophiagenetics.com
  • Company Address: 185 Dartmouth Street, Suite 502, Boston, MA, 02116

About SOPHiA GENETICS

SOPHiA GENETICS combines deep expertise in life sciences and medical disciplines with mathematical capabilities in data computing. Our mission is to bring data analytics solutions to market, to support healthcare professionals by maximizing the power of Data-Driven Medicine. We achieve this mission through the global adoption of SOPHiA AI, which is built using techniques such as statistical inference, pattern recognition and machine learning. This enables SOPHiA to provide equal benefits to all users, unite experts in a gold standard health tech platform, and motivate expert knowledge sharing for a sustainable impact on future patients.

Job Description

Would you like to be part of a dynamic and exciting team delivering high level performance that has a direct impact on the lives of cancer and rare disease patients worldwide? Join our growing team and use your exceptional technical and organisational skills to help us deliver on our mission of democratising Data-Driven Medicine. Our products are used by over a thousand healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.

Be part of our mission to disrupt the healthcare and democratise the data driven medicine! SOPHiA GENETICS is looking for a Software Validation Engineer to join the Quality Assurance and Regulatory Affairs (QARA) team at our headquarters in St-Sulpice, Switzerland.

Reporting to the Knowledge Management lead, you will be responsible for the maintenance and monitoring of core QARA systems, and for the validation of software company-wide. You will play a vital role on cross-functional initiatives to validate various in-house and enterprise software such as, but not limited to, our Learning Management System (LMS), Quality Management System (QMS), Digital Asset Management System (DAM), and various software used during product design. For success in this role you must be comfortable with basic programming, scripting, sys-admin and working on parallel projects with multi-national teams.

Mission

    You will ensure all software used for QARA functions and company-wide product design and development are kept up to date at all times.
    You will ensure compliance of support systems such as MS Active Directory, Atlassian JIRA & Confluence, etc.
    You will support internal stakeholders from different departments to ensure that their software meets requirements.
    You will write, maintaing and update KM quality documents (SOP’s, forms, Work Instructions).
    You will performe routine data backups, inspections and quality tests.

Requirements

Overall

    Bachelor’s degree in computer science, data science or related field.
    2 - 5 years of experience in IT admin; biotech/medtech industry a plus.
    Strong analytical skills, proficiency in one or more programming languages, familiarity with different operating systems, (macOS, Linux, windows).
    Strong knowledge and experience with MS Active Directory, ADFS, Atlassian JIRA projects and workflows, Confluence.
    Basic knowledge of Software Development Life Cycles;

    Programming languages: basic knowledge of Python, Java, Bash.
    Good knowledge of NIX systems.
    Ability to coordinate projects at multiple levels.
    Mandatory C1 english level required (spoken and written)

Requirements engineering

    Requirements elicitation, specification and management
    Requirements management tools (e.g. IBM DOORS, Jama Connect, etc.).

Software verification and validation

    Proven experience with IQ / OQ / PQ
    Specification and execution of verification and validation protocols

    Analysis and documentation of test scenarios and test cases
    Automation testing platforms (e.g. Bamboo, IBM Rational Test, HP ALM, etc.).

Plus

    Knowledge of ISO 25065, IEEE Std 830 or other similar standard/guidelines (requirements specification)

    Knowledge of IEEE 1012, ISO/IEC 29119 or other related standards (V&V)
    Knowledge of GAMP5 or GxP quality guidelines in general
    ISO/FDA regulation for software medical devices (e.g. IEC 62034, ISO 14971, FDA 21 CFR 820.30, AAMI TIR45).
    FDA 21 CFR 11

Benefits

    Career opportunities in a fast-growing company with worldwide reputation

    A flexible and friendly working environment with a collaborative atmosphere
    Fantastic office locations in Switzerland.
    An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
    A fast-growing company with plenty of opportunity for personal growth and development

Start: ASAP

Contract type: full-time

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.