Oxford Immunotec, Inc.

Quality Software & Automation Engineer

Job Location UK-Milton Park, Abingdon
Posted Date 5 months ago(1/13/2021 4:45 AM)
ID
2020-2118
# of Openings
1
Department
Quality & Regulatory

Overview

Responsible for Quality software life cycle processes (including computer software validation) and automation following Oxford Immunotec quality management system (QMS) in relevant manufacturing and clinical laboratory facilities and in accordance with IEC62304.

The role will interact and work closely with the UK Quality and Regulatory team. In addition, the role will work closely with IT, Development and ODL teams on software and automation processes and systems, which impact the Company QMS and Products.

Responsibilities

  • Manage and develop the eQMS system EtQ Reliance as per applicable standards.
  • Effectively manages all assigned software life cycle process and automation projects through developing process, design, verification and validation strategies, and associated documentation. These will be developed against the relevant software life cycle process and automation solution requirements and procedures to ensure that compliance and project needs are achieved.
  • Assist in the implementation, maintenance and continuous improvement of company-wide ERP system, assisting in the Quality modules, full validation and any necessary or desired adaptations.
  • Collaborate to develop and deploy regulatory and quality systems strategies in compliance with all requirements, including input to research and development programs, processes and procedures that yield products that are capable of early product approval by regulators.
  • Collaborate to develop OI’s software development and life cycle process capabilities to support agile and commercially viable development of new technologies (including AI and machine learning algorithms), instrumentation and automation strategies
  • Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
  • Provide quality guidance and assessment to ensure validated systems are maintained and managed in accordance with regulatory requirements. Operate effectively across departmental and local boundaries to resolve Quality-related issues in collaboration with peer group and senior managers
  • Follow all company safety policies & other safety precautions within work area
  • Regular attendance and timeliness is essential
  • Working to Oxford Immunotec’s Company Values at all times

Qualifications

  • A degree in the sciences or equivalent
  • 3+ years relevant work experience
  • Good knowledge of Quality Management Systems, especially in conjunction with OI QMS and the relevant standards including ISO13485:2016, ISO 14971:2019, IEC62304:2006A1, 17025:2017, 21 CFR, part 820, 21 CFR, part 11, GAMP 5, cybersecurity and data integrity regulations.
  • Significant experience in quality systems related aspects of software development and life cycle processes, and/or related lab-based automation or instrumentation systems would be a distinct advantage
  • Understanding of the scientific, biological, technical and logistical issues involved in developing software for diagnostic assays and /or running commercial clinical laboratories
  • Good written and oral communication skills
  • Ability to think analytically and identify solutions to solve problems
  • Team player and strong leader with a cooperative and proactive attitude

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