Sector: Life Sciences
Consultant: Harvey Havell
Salary: £35000 - £45000
Job Status: Permanent / Full Time
Job Role: QA Software Engineer
Hours: Full time (40 hours)
Remuneration: Dependent on experience
Drive all elements of software quality assurance support to manufacture a range of medical devices; including product development, manufacturing operations, information systems, and quality systems activities.
Ensure external and internal quality system requirements are adhered to throughout product and process lifecycles.
Develop and implement software design plans, detailed design specifications, design verification/validation plans, test protocols/reports, traceability matrices and risk assessments.
Additional emphasis will be placed on Software Validation activities.
Perform risk assessments and validation assessments for product and process software changes.
Lead the software risk management process throughout the entire product lifecycle.
Lead a team through investigations and corrective actions for software related CAPAs.
Maintain a working knowledge of applicable regulatory standards and requirements.
Maintain and continually improve Software Quality System procedures representing best practices and GMP, ensuring that the procedures meet all applicable regulatory standards and requirements.
Develop development and training protocols and deliver to employees on principles of software validation, software risk management, and general software quality tools.
Education & Experience:
B.S. degree in Computer Science, Engineering, Biology, Chemistry or related discipline.
5+ years’ experience in Quality Engineering, information systems, computer science or management preferably in a regulated industry.
One year in a leadership role for product software validation and software quality assurance activities. (desirable not mandatory)
Working experience of regulations relating to in-vitro diagnostic medical device products and software (e.g. FDA’s “General Principles of Software Validation and “Guidance for the Content of Premarket Submission for Software Contained in Medical Devices , 21CFR Part820, 21CFR Part 11, EN ISO 13485, IEC 60601, EN ISO 14971:2012, IEC 62304). Emphasis will be placed on experience with the CE technical files.
Experience in Software Development Life Cycle activities and understanding of software design inputs and outputs.
Working knowledge of product software, analytical process software, manufacturing process software, and quality system software validation methods and requirement
All listed tasks and responsibilities are deemed as essential functions to this position;
however, reasonable accommodations will be made if at all possible under business conditions.
If this is of interest, please click apply now to submit your CV. For more infomation, please contact Harvey or Steve in the Life Sciences team.