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Senior CSV-Software Quality Engineer

  • Job reference: 922841
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 05/12/2018

Orion Group are recruiting for a Senior CSV/ Software Quality Engineer Inverness on a permanent basis for our multinational medical device company.

It is an exciting opportunity for a Senior CSV/ Software Quality Engineer to join the team in northern Scotland. 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 companies 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.

Key attributes of the successful candidate

  • 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

Desired Experience and Background of the successful candidate

  • 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


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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