Medical Device Software Quality Engineer at Deciphex | chakrie

Requirements

Additional Requirements

Degree or equivalent in a relevant discipline (e.g. life sciences, engineering, quality management, regulatory affairs) or equivalent experience.
Training or coursework in ISO 13485 or quality management systems is desirable.
Regulatory affairs training (e.g. RAC coursework) or internal audit training is an advantage.
Minimum 3 years of experience in a quality, regulatory, or related role in a medical device, IVD, pharmaceutical, or regulated software environment
Experience with digital pathology systems and AI based digital pathology diagnostics is a distinct advantage
Good working knowledge with ISO 13485 QMS requirements or FDA 21 CFR Part 820; exposure to UK, EU, MDSAP or Health Canada medical device regulations is desirable.
Good working knowledge with software as a medical device (SaMD) or IVD software concepts including IEC 62304, is desirable.
Experience with document control, CAPA, complaint handling, or audit support processes in a regulated environment is an advantage.
Exposure to FDA regulatory databases (e.g. FURLS, GUDID) or Health Canada device licensing portal is desirable; willingness to learn these systems is essential.
Experience with eQMS or quality management software tools is an advantage.
Experience with GCP requirements and clinical evaluations for SaMD is an advantage.
Working knowledge of or willingness to develop proficiency in ISO 13485:2016 and FDA 21 CFR Part 820; ability to apply requirements to day-to-day quality operations in a software/IVD environment.
Basic familiarity with US FDA medical device regulatory pathways (510(k), De Novo) and Health Canada medical device licence requirements; willingness to develop working knowledge of MDSAP and applicable US/Canadian regulations.
Exceptional attention to detail in maintaining controlled documents, records and registers; proficiency in managing version-controlled documentation in an eQMS or equivalent system.
Proficiency in tracking and reporting quality metrics (e.g. CAPA closure rates, complaint volumes, audit findings); ability to build and maintain dashboards or summary reports using spreadsheet tools or quality software.
Ability to manage multiple tasks, track deadlines and maintain accurate records simultaneously across QMS and regulatory activities.
Ability to communicate clearly with cross-functional teams, suppliers and the Quality and Regulatory Affairs Manager in a remote or hybrid environment.
Demonstrated willingness to develop technical knowledge and take on increasing responsibility within the quality and regulatory function under the guidance of the Manager.
Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age
family or marital status (including pregnancy)
membership of the traveling community or any other classification protected by applicable law.

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Salary & benefits

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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Medical Device Software Quality Engineer

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