Location: Cambridge

About electronRx:

As a deep tech company, electronRx’s mission is to ensure that innovative technologies in the healthcare sector meet the highest quality and compliance standards. We are at the forefront of transforming healthcare through advanced digital solutions, and we are seeking a dynamic and experienced Quality Manager to join our team.

The role:
As the Quality Manager, you will play a pivotal role in overseeing the quality management system for our healthcare digital devices. You will be responsible for ensuring that our products comply with relevant regulations, standards, and industry best practices. The successful candidate will collaborate with our QMS lead and other cross-functional teams, regulators, and external partners to maintain quality standards to meet internal and external requirements throughout the product lifecycle.

 

Key Responsibilities:

• Quality Management System (QMS)

  • Development and Oversight:

  • ​Maintain an effective ISO 13485:2016 compliant QMS for SaMD healthcare digital services

  • Ensure compliance with relevant regulatory standards

  • Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) and design change control requirements are met.

• Regulatory Compliance:

  • Stay abreast of evolving regulations in the healthcare and technology sectors.

  • Collaborate with the regulatory affairs team to ensure product submissions meet regulatory requirements.

• Risk Management

  • Identify and assess risks associated with product quality and compliance.​

  • ​Review and Implement risk mitigation strategies to ensure product safety and efficacy.

• Supplier Quality Management:​

  • Collaborate with suppliers to establish and maintain standards for components and materials.​​​​

  • Conduct supplier audits and assessments to ensure compliance.

• Cross-functional Collaboration:​

  • Work closely with R&D, advisors, and regulatory affairs teams to integrate quality into product development processes.

  • Provide quality input during design reviews and change control processes.

• Quality Metrics and Reporting:​

  • Establish and monitor key quality metrics and performance indicators.

  • Generate regular reports on quality performance for management review.

• Training and Development:​

  • ​Develop and deliver training programs on quality processes, regulations, and best practices for internal teams.​

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Qualifications:

• Bachelor's degree in a relevant field; advanced degree preferred.

• Minimum of 5 years of experience in quality management within the healthcare or medical device industry.

• Comprehensive knowledge of EUR MDR  and other global quality standards.

• Proven experience in risk management, supplier quality management, and regulatory compliance.

• Strong communication and interpersonal skills with the ability to collaborate effectively across diverse teams.

• Strong organizational and project management skills with attention to detail and accuracy​​

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What We Offer:
● A progressive and supportive workplace which encourages you to flourish authentically and the opportunity to upskill yourself.
● Shared open work spaces in a collaborative environment with free refreshments.
● An opportunity to work with some of the most talented experts from numerous different fields.
● Invaluable experience in building a company and a product from the ground up.
● A central Cambridge office with secure parking and bike storage.
● A feeling of fulfilment knowing that you are working to make a positive impact on the lives of others.

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Diversity and Inclusion
Diversity, inclusion and equal opportunity are at the very core of who we are. We’re working to improve healthcare for everyone, everywhere; shifting the paradigm from generalised to personalised medicine where every patient is treated as the unique individual they are, and we take the same approach to building out our team!

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As such we’re proudly diverse - we welcome and encourage applications from all members of our community, regardless of race, religion, gender identity, sexual orientation, class status or national origin.

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GDPR
When applying for this position, you are giving eRx the permission to hold your data for recruitment purposes. Any information provided will be stored securely in line with current data protection regulations and used for recruitment purposes only.