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Software Quality Engineer

  • Job reference: LKINSQE
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 10/07/2018

Orion Group are recruiting a Senior CSV/ Software Quality Engineer for a contract role located in Inverness Scotland.

Role Profile:

To provide day-to-day support, supervision as required and prioritization of a team of engineers with expertise in Computer Systems and Computer Systems Validation. T

The Senior CSV/ Software Quality Engineer provides 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.

Qualifications:

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

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

Knowledge:


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

Quality systems

Working knowledge of design control

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, a minimum of 3 of these years 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


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.