Manager Design & Development Quality

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Our lawsuit are a aesculapian instrumentality diagnostics institution that is transforming community-based healthcare. The institution manufacture innovative products are being successful galore settings to diagnose and show wellness arsenic good arsenic disease. The institution is connected the marketplace and successful improvement of 30+ tests.

They are looking to adhd a Manager to the squad to pb instrumentation Design & Development Quality. This relation is based successful Scotland supporting each activities associated with instrumentation and connectivity plan & improvement i.e. software, hardware, mechanical, electrical, connectivity and associated investigating defined successful the institution QMS.

Responsibilities:

  • Quality Compliance - Support instrumentation departments to guarantee Audit Readiness
  • Identify gaps & Opportunities For Improvement and supply prime expertise/training
  • Develop and execute due processes for consistent, technical, risk-based determination making
  • The Manager Design & Development Quality volition show prime performance
  • Manage QA activities associated with instrumentation plan & development, alteration management, V&V, method investigations
  • Key interaction ensuring each QA activities are completed.
  • Provide regular task presumption updates to applicable QA, task and method teams.
  • Escalate immoderate issues connected Compliance; Timelines; Resource; Readiness.
  • People absorption - Responsible for hiring, managing, coaching & processing the QA instrumentation squad to present concern goals
  • Design & Development Quality Assurance - Manage plan prime activities associated with instrumentation.
  • The Manager Design & Development Quality volition supply proposal & enactment for regulatory submissions acting arsenic interface betwixt RA & method teams connected requirements.
  • Change absorption & plan transportation - Provide prime expertise into alteration absorption and plan transportation associated with instrumentation successful compliance.
  • Input to task meetings, plan and process FMEA's, documentation requirements, prime process updates and alignment with immoderate regulatory requirements.
  • Quality events & CAPA - supply prime expertise and guidance into Quality Event & CAPA reports and escalation of precocious hazard issues.
  • Process Improvements - enactment with prime unit crossed sites to align connected Quality requirements for the concern and lead/support prime betterment projects.

Skills/Qualifications:

  • Knowledge and acquisition of moving to prime and regulatory standards including ISO13485, FDA21CFR Part 820, ISO 14971
  • Awareness of required method standards e.g. Usability, Medical Device Software, Safety, Cybersecurity, EMC etc.
  • Instrument improvement & Design Quality
  • People management
  • Degree oregon equivalent level attained done applicable experience
  • Exposure to IVDs would beryllium preferred but not a woody breaker

To find retired much astir Real delight sojourn www.realstaffing.com

Real Staffing, a trading part of SThree Partnership LLP is acting arsenic an Employment Agency successful narration to this vacancy| Registered bureau | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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