Senior CSV/ Software Quality Engineer

Ark Talent
31 Mar 2019
10 May 2019
Contract Type
Full Time
Senior CSV/ Software Quality Engineer

Our client is a world leading manufacturer of medical devices such as diabetes and blood glucose monitoring and testing kits. They are now looking for a Senior CSV engineer to join their team in Scotland.

The responsibilities include providing day-to-day support, supervision as required and prioritization of a team of engineers with expertise in Computer Systems and Computer Systems Validation. To provide initiative and leadership to implement systems and processes that are aligned with the overall quality and business vision in compliance with the applicable regulatory and company requirements.

The Senior CSV/ Software Quality Engineer will provide a high level of technical knowledge and practical experience of Computer Systems and Computer Software Validation, which includes, automated manufacturing systems, automated quality systems and tools, computer applications for business, bespoke computer software specification, design and systems testing.

Role responsibilities:

-Prioritise CSV team and own workload to meet deadlines and Implement day-to-day priorities in line with business needs

-Serve as CSV department Subject Matter Expert (SME), represent Quality and present CSV validation documentation during internal and external inspections - recognised as the CSV go to person

-Coach others in the CSV function, provide coaching, feedback and direction to project teams

-Translates a given strategy into tactics and measures, independently. May participate in strategy development

-Leads complex validation projects and projects within own function. Significant involvement in cross functional and global projects

-Guide Project Managers, Project Owners & Project Teams regarding specific CSV requirements & responsibilities

-Resolve & manage technical operational problems, provide solutions to difficult technical issues. Influence and persuade to bring about technical and process improvements

-Resolves issues through constructive negotiation and professional behaviour

-Makes decisions based on data. Understands the balance of day-to-day activities versus big picture. Can assess risk and act appropriately

-Keep management informed and escalates issues as appropriate

-Review and approve CSV validation and quality system documentation

-Ensure validation activities and documents are authorised and appropriate compliance approval is gained

-Provide periodic validation review support to current regulatory and company standards through the QMS

-Lead by example, inculcating the Credo values in all actions within the workplace and promote the value of diverse perspectives. Facilitate and foster successful team behaviour

-Proactive & forward thinking. Drives & implements continuous CSV function and process improvement activities. Implementing initiatives that will deliver customer value at lowest cost

-Influence business partners & suppliers to ensure product quality and compliance to quality systems

-Leads CSV activities related to transfer of product design into operations

-Understands the breadth of quality system and how it fits into the wider business perspective

Ideal Candidate:

-Degree qualification in an appropriate engineering discipline or equivalent work-related experience within in a regulated industry

-Formal problem-solving techniques, e.g. PeX green belt certification

-SME knowledge of computer systems & software design, development and validation

-Working knowledge of design control and Quality Systems

-Product lifecycle and manufacturing knowledge

-Risk management tools e.g. FMEA, SRA, DOE

-Software configuration management and change control

-Experience on computer systems and software development validation and/or testing activities, must be from working in a regulated industry

- Working knowledge of FDA & European Regulations relating to the Medical Devices Industry and best practices guidelines i.e. 21 CFR Part 11, 820 & ISO 13485 and GAMP

-Knowledge of bespoke computer systems, software/application and hardware specification, development, testing and documentation within a regulated industry

- Knowledge of automated manufacturing equipment, inspections systems, PLC, SCADA & DCS, specification, development, testing and validation

- Self-motivated/ directed; ability to work with minimal direct supervision

- Good time management and ability to prioritize and manage many ongoing projects at the same time, both for self and department

- Technical training / coaching of staff

Trouble shooting and problem-solving skills


- Master’s degree

- Chartered status in relevant discipline

- Advanced formal problem-solving techniques, e.g. PeX Black Belt certification

- ASQ certification or equivalent

-ISEB Software Testing certified

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