Senior CSV/ Software Quality Engineer - Medical Devices - Inverness - Permanent £Comp
SRG are working with a world leading medical device manufacturer based in Inverness on a permanent CSV position. This role is a wonderful opportunity for an experienced CSV / Software professional who wants to support the validation team in relation to Computer Systems. This role will also provide the opportunity to mentor and coach a team of more junior engineers thus allowing for career progression and continuous learning.
Responsibilities within Role;
* Awareness of Computer Systems regulations* Computer Validation* Ability to work independently as well as part of an interdisciplinary team* Motivational and Influencing approach with strong communication skills* Bespoke software and/or hardware build, testing, documentation and deployment As a Senior CSV/ Software Quality Engineer, your typical day may include: * Organise, lead validation working parties associated with computer systems and provide timely validation support to identified stakeholders.* Carry out general investigative work using the QMS tool and implementing controls to mitigate the compliance risks from the investigation.* Provide validation periodic review support to the business in all aspects of software development lifecycle processes.* Provide audit support to the business in all aspects of software development lifecycle processes.* Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations Qualifications; * Degree qualified in a relevant discipline such as Electrical/ Electronic Engineering, Information Systems or Life Sciences with additional IT Knowledge* Experience of working within a regulated industry carrying out verification and validation activities.* In-depth knowledge of Medical Device or Pharma industry regulations; FDA, ISO, and industry best practices; GAMP/PICS* Knowledge of bespoke software and/or hardware build, testing, documentation and deployment as part of software and/or system development lifecycle* Knowledge of document and change management process* Working knowledge of risk management tools e.g. FMEA, FTA or SRA* Proactive problem resolution * Self-directed; ability to work with minimal supervision as part of an interdisciplinary team* Strong communication, both written and oral, with all levels of the business* Proven mentoring/ coaching experience, either formally or informally achieved. If interested in this role please send an updated CV or call 07490217352 for more information.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.