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Senior CSV/ Software Quality Engineer

With a performance related bonus target of 9%. Career Average pension scheme, Life Assurance, Income Protection Plan, B - Medical/Pharmaceutical - Quality
Ref: 214 Date Posted: Tuesday 17 Jul 2018
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Senior CSV/Software Quality Engineer

Inverness, UK

Are you looking for a dynamic, diverse environment that will challenge and inspire you?

Our client has an exciting opportunity for a Senior CSV/ Software Quality Engineer to join their team in Inverness. This is a senior role within the team, providing leadership support for validation activities relating to Computer Systems. This role is key in ensuring that all compliance issues and requirements of the company’s validation policies and procedures are followed and maintained to a high standard. The Senior CSV/ Software Quality Engineer will also help mentor and coach the team providing development support and ensuring ongoing development and Continuous Improvement for the team.

 

What you’re great at:

  • 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

 

What you’ll own and how you’ll grow: 

You will own the computerized validation process, including periodic review attributes. You will also own the continuous Improvement elements; making improvements to the established process whilst maintaining regulatory requirements are maintained.

This is an exciting time to join the expanding team, moving forward with a new structure which will allow you the opportunity to shape the team and the way the company works in the future.

You will be supported to develop both technically and personally.  You will also be rewarded by knowing you are helping patients across the world.

 

BE VITAL:

To be part of this high performing team you will have great attention to detail, alongside

  • 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.

 

What the company is about:

They are passionate about their work, and play vital roles across a range of professional disciplines, and care deeply about their customers and communities. The culture enables dynamic and impactful careers. Employees share a kind of DNA where each are:

  • Committed to caring
  • Responsible to communities
  • Ready to apply knowledge and know-how
  • Unique in background and experiences
  • The drivers of own success
  • Passionate about doing what’s right

 

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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