Quality Engineer

Abselion; Cambridge; On-site; GBP 40,000 - 55,000; Full time

Job description

About the job Quality Engineer

Quality Engineer (Job ID 5356)

Full-time (100%)

The company

At Abselion we're on a mission to revolutionize protein research. Our vision is to empower scientists to focus on discovery and innovation, not tedious manual tasks. We have created Amperia, a compact, affordable benchtop solution designed to simplify protein research for everyone. Amperia helps researchers to develop the medicine of the future, find the best ways to produce novel biomolecules, and ensure that medicine is always safe and efficacious.

We are a dynamic, interdisciplinary team working at the intersection of biotechnology and engineering. We value a flat hierarchy, where everyone is encouraged to share their ideas and follow their passion. We are supported by some of the leading investors and companies in the biopharmaceutical industry.

The role

At Abselion, we are looking for a Quality Engineer to help support the production scale-up and expansion to international markets. We are looking for someone who will be able to ensure our products are compliant with local regulations and will work with the governing bodies to meet product approval. Working with the engineering department to maintain design control and take ownership of the engineering change request process to ensure that the technical file is up to date and ready for auditing.

In addition, you will work with Production Tine to improve our production processes with traceable quality checks. Your responsibilities also include monitoring of health and safety, especially around reagent handling. In the long term, you will support the implementation of best practices with the goal of achieving ISO9001 certification. This is a unique chance to contribute to the growth of a dynamic biotech company and play a key role in our journey.

Your responsibilities

• Regulatory Compliance:
  • Obtain and maintain product compliance across UK, US, and Europe.
  • Conduct Gap analyses of current processes.
  • Implement a companywide Quality Management System.
  • Prepare and maintain documentation, i.e. Technical file, Batch records.
• Quality Assurance & Control:
  • Implement and monitor quality control systems to ensure product quality meets the US market's specifications.
  • Perform quality audits and manage internal audits to assess adherence to US regulatory standards and best practices.
  • Lead corrective and preventive actions (CAPA) for non-conformances.
• Documentation & Reporting:
  • Develop and maintain test plans, inspection procedures, and other quality documentation required for US regulatory compliance.
  • Create and review processes and generate templates consistent with good documentation practice.
  • Carry out Risk assessments.
  • Improve Health and Safety business-wide, starting with consumable reagent handling.
• Product Development and Design
  • Own the Engineering Change Request process to ensure design control and ongoing instrument compliance.
  • Participate in design reviews, DFMEA, and PFMEAs to ensure regulatory requirements are met early in the development process.

Requirements

• 5+ years in a quality engineer role in the appropriate industry.
• Relevant degree to at least BSc, or apprentice to HNC with additional training.
• Understanding of UK, US, and EU compliance.
• Good technical knowledge of quality management.
• Experience being audited for ISO9001 or UL61010 compliance.
• Good problem solver.

What we offer

• Dynamic and fast-paced work environment in a rapidly expanding company.
• Be part of a step-change in life science instrumentation.
• Working on cutting-edge technology at the intersection of biology, engineering, and data science.
• Most important of all, join a great team!
• Share option scheme.
• Base salary between £40-55k.

Start date

Immediate

Location

The role is on-site located in Cambridge, UK.

Application process

First stage: Video or phone call; Second stage: Technical interview; Final stage: Face-to-face interview with the team.

How to apply

Please fill in the application form on our Careers page and attach your CV in PDF format. We look forward to receiving your application.