Quality Assurance Specialist

2 weeks ago

Melbourn, Cambridgeshire, United Kingdom PA Consulting Full time
Job Description

We are seeking an exceptional Quality Engineer to support the DES Quality Manager in maintaining and supporting the current quality management system and ensuring compliance with quality, regulatory, and customer requirements.

This role involves working closely with the Quality Manager to maintain the QMS, contribute to external audits, and work with consultants to provide support and advice. The successful candidate will have a thorough understanding of ISO 9001 and ISO 13485 quality systems and be able to develop, learn, and broaden out across multiple sectors to get to grips with best practice and applicable regulations.

Key Responsibilities
  • Support the Quality Manager with the maintenance of the QMS
  • Contribute to external audits from ISO certification bodies for the QMS and from clients undertaking supplier approval audits for work
  • Work with our consultants to provide support and advice, as well as engaging and empowering colleagues to take ownership of best practice, and codify it in the QMS
  • Usage and deployment of eQMS systems to drive change in the business that supports colleagues and improves compliance
  • Work to deliver the internal audit plan with stakeholders and undertake audits to assess effectiveness of both work and QMS, managing the CAPA process
  • Contribute to quality metrics, assess performance against them and report findings
  • Contribute to management review meetings by helping to compile the summary reports assessing the effectiveness of the management system and help develop the strategy and long-term plans
  • Train colleagues on QMS processes and develop innovative ways to engage and support the consultancy team to improve familiarity with the management system and meet PA's targets
  • Support client projects, specifically in more highly regulated industries, ensuring activities meet relevant Quality standards / design controls for medical / drug delivery devices
Requirements
  • A Quality Practitioner with experience in operational quality assurance
  • Working understanding of either ISO standards ISO9001 or ISO13485
  • Great communication skills for interactions with training staff, and external audits, which may include clients and certification bodies
  • A willingness to engage across a multi-disciplinary environment
  • The ability to develop, learn and broaden out across multiple sectors to get to grips with best practice and applicable regulations
About PA Consulting

PA Consulting is a global consulting firm that helps businesses, governments, and organizations solve complex problems and improve performance. We have a diverse team of experts who work together to deliver innovative solutions that drive growth and transformation.

We are committed to creating a workplace that is inclusive, diverse, and respectful. We believe that diversity fuels ingenuity and that our people are our greatest asset. We offer a range of benefits and opportunities to support the physical, emotional, social, and financial well-being of our people.

Join us and be part of a team that is shaping the future of business and society.

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