Quality Manager

Quality Manager

Posted Mar 20 2019

UK or US Remote

Full time

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What will you do

The Quality Manager is a critical role for our growth. This role will take responsibility in maintaining and enhancing our operational and quality systems to ensure compliance with our internal and external regulatory standards. You will be involved in every stage of the product life cycle and its deployment having a crucial input in building the best possible product that saves people’s lives.

It is expected that the person in this role will utilise their expertise to guide our team in interpreting policies and regulations assure compliance by default. You will help the team prepare reports and documentation ensuring the Quality Management System is kept up to date and in line with product developments. The role will take the lead on audits and inspection preparation, ensure successful resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.

Responsibilities
• Act as a leader of global quality, influencing a “Quality By Default” culture and owning our Quality Management System (QMS).
• Development and maintenance of the QMS that meets Regulatory and business expectations for physical medical devices and software as a medical device.
• Augment and improve the QMS to reflect both best practices and internal development process.
• Maintain our organisational knowledge of laws and regulations, provide oversight of current and evolving regulatory requirements to ensure the QMS remains current.
• Be an active participant in the product development lifecycle, advising on quality management requirements and ensuring these developments are supported by the QMS.
• Establish and improve product lifecycle processes to ensure quality is maintained at the heart of our development strategy.
• Perform internal audits and assessments as applicable. Ensure readiness for and hosting Notified Body audits.
• Maintaining documentation such as design dossiers, technical files and Declarations of Conformity.
• Evaluating and monitoring sub-contractor compliance and maintaining Technical Agreements as appropriate.


About you

  • Past experience of working in a startup culture is preferred.
  • Proven experience of managing Quality Assurance in the Medical Device Industry with ownership of a quality management system a must.
  • Recent experience with complex electronic, electro-mechanical and a software as a medical device.
  • Demonstrable experience of conducting quality reviews, internal quality audits and reporting on system performance. being Certified Auditor will be considered a significant plus.
  • Strong and practical knowledge of ISO 13485, FDA CFR 820, MDSAP, MDD and MDR as well as emerging standards and regulations.
  • Strong experience in Regulatory Affairs and/or Quality with demonstrated experience in the full range of submissions and in dealing with local and international regulatory agencies including the FDA
  • Experienced in writing/submitting 510k’s and CE Technical Files.
  • A BSC degree or equivalent in a Life Sciences field would be ideal
  • You are flexible and can learn on the job quickly
  • It is important you can pragmatically balance quality with a fast-paced schedule
  • You are a good team player, ready to help, debate, compromise and work together
  • You are comfortable working, prototyping and delivering incrementally, adapting based on customer needs and technical difficulties, always with the user in mind
  • Have the ability to work with people across all levels and teams
  • You have an eye for detail
  • You always look at the big picture
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