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Quality Systems Manager - Remote Based

Job Type
7 Sep 2022
Global Quality Systems Manager - Remote Based Global Quality Systems Manager (Remote Based) required for a fantastic opportunity to join my client, a global leader in the design and manufacture of electro-mechanical solutions and products for a range of industries. This opportunity offers an enriched and broad scope that involves working collaboratively with teams in supply chain, quality, engineering, and project management. With a keen eye to detail, and a customer- focused approach, the primary focuses of this role includes delivering an effective, efficient, and proactive Enterprise Quality Management System (eQMS) to enable business success. Responsibilities of the Global Quality Systems Manager: Implementing eQMS software platform across supply and sales site. Collaborate with production to develop and implement controls and improvements. Monitor and analyze quality performance and collaborate with the manufacturing and engineering teams as well as lead improvement opportunities. Identify, investigate and assess risk of specific product / process non-conformances and develop corrective actions, and improvements as required. Provide ongoing support for sustainment of electronic systems, records, design of operational reports and dashboards and processes Provide support for integration of eQMS with other computerized systems (eg. LIMS, LMS, PLM, ERP, etc.) Ensure the solution is consistently audit ready and assist in audit coordination to deliver successful results Use statistical analysis and quality techniques to collate, trend and analyse quality KPIs Experience and Skills of the Global Quality Systems Manager: Ideally experience in a medical-device, pharmaceutical, biotech or other regulated industry Advanced organization and project management skills. Experience sustaining or validating computer systems (e.g. QMS, PLM, LIMS, LMS, ERP, MES, etc.) in a regulated environment. Travel internationally (up to 35%) to provide support to sites with investigation training, Understanding of current software quality-assurance risk-based techniques and their impact on internal procedures, product safety and efficacy Strong working knowledge of medical device regulations and standards, including 21 CFR 820, 21 CFR 11, ISO 13485 and other global medical device and electronic records regulations and standards Highly effective interpersonal, verbal and written communication and organizational skills, with a self-motivated, achievement orientation Demonstrated experience partnering, navigating conflict, and influencing teams cross functionally Knowledge of global regulatory requirements for systems validation methods and solution assurance using risk-based approaches Ability to drive functional, technical and operational excellence. Excellent analytic, leadership and communication skills. ENG1
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  • Job Reference: 706585735-2
  • Date Posted: 7 September 2022
  • Recruiter: RE People
    RE People
  • Location: Birmingham
  • Salary: £40,000
  • Bonus/Benefits: benefits
  • Sector: Engineering
  • Job Type: Permanent