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Quality Engineer

Key Responsibilities

  • Management of process deviations, non-conformance, reworks, CAPA, Design Changes, complaints, scrap and change requests for product group
  • Support operations through the product life-cycle
  • Lead and/or proactively participate in cross functional investigations as required
  • Lead and/or proactively participate in risk management activities for designated product groups and processes as required
  • Support Validation activities for designated product groups
  • Conduct process and GMP audits and ensure area compliance
  • Liaise with regulatory department to ensure product supply is maintained and all quality aspects are met

Competencies

  • Foster collaborative relationships within the team and across the organisation. Accepts feedback from others and uses this information to improve performance and relationships.
  • Respond to information requests from others in a timely manner. Keep manager and team aware of any changes or potential issues.
  • Proactively identify and hi-lights problems that will prevent achievement of goals. Collect, analyse, and interpret data to draw key conclusions that aid in decision making and day-to-day operations.
  • Comply with industry and professional standards and certifications in technical/functional area.
  • Take ownership for assignments and requires minimal supervision to accomplish tasks. Show passion and enthusiasm for the company, industry, and own work even in challenging circumstances
  • Champion QA and continuous improvement initiatives

Qualifications & Experience

  • Primary degree qualification in a science, engineering or business discipline
  • Minimum 4 year experience in diagnostics, medical device or life science industry

Skills and Behaviours

  • Ability to articulate and gain consensus for the Quality perspective in departmental decisions; provide effective solutions for key department stakeholders
  • Excellent verbal and written communication skills
  • In-depth knowledge of International Standards, GLP and GMP

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales