Quality Engineer

About ANGLE:

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected circulating tumor cell (CTC) harvesting technology is known as the Parsortix® system. ANGLE's Parsortix® system is FDA cleared for its intended use in metastatic breast cancer and is currently the first and only FDA cleared medical device to harvest intact circulating cancer cells from blood.

The Parsortix system enables a liquid biopsy (a simple blood test) to be used to provide the circulating metastatic breast cancer cells to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all phenotypes of CTCs (epithelial, mesenchymal and EMTing CTCs) as well as CTC clusters in a viable form (alive). CTCs harvested from the system enable a complete picture of a cancer to be seen; as being an intact cell they allow DNA, RNA and protein analysis as well as cytological and morphological examination and may provide comparable analysis to a tissue biopsy in metastatic breast cancer. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient.

Join our Team:

This is an exciting time at ANGLE and our team in Guildford are looking for a Quality Engineer to ensure that products and services meet quality standards. This includes developing and implementing quality procedures and processes, inspecting products and services, identifying, and resolving quality issues, and ensuring compliance with all quality system standards and regulations. The Quality engineer will play a vital role in ensuring that products and services are safe, reliable, and meet customer expectations.

At ANGLE, we foster a dynamic, entrepreneurial approach to translating leading edge translational research into clinical diagnostics. We promote a culture of collaboration and shared excellence while encouraging an open and honest exchange of ideas.

We are always in search of potential employees who share our vision and want to make a difference today. In your submission, please describe your background and what you can bring to our team along with attaching your resume.

Principal Accountabilities:

• Help develop quality plans and inspection plans for new products and services.
• Inspect products and services to ensure compliance with quality standards.
• Review, maintain, and update quality system documentation in accordance with ANGLE's document control processes, ensuring it reflects current practices.
• Identify and resolve quality issues and report them through the defect or CAPA system.
• Conduct audits and risk assessments to ensure compliance with quality standards.
• Work with other engineers to incorporate quality into their processes.
• Mentor and train other quality personnel.
• Help develop and maintain ANGLE's quality management systems (QMS).
• Ensure that defect reports for all areas of the business, service, development, and manufacturing are raised promptly and followed up on during defect meetings.
• Create, risk assess, and analyse trends of occurrences and file defect reports accordingly to ensure the quality of the product is not compromised.
• Lead defect and design-related defect meetings to ensure that supplier defects and design-related problems are resolved promptly.
• Help resolve all service and engineering related CAPAs.
• Review and maintain all engineering change requests, rework, and concessions to ensure that related processes and procedures are updated accordingly as necessary to prevent the quality of the product from being compromised.
• Provide quarterly FMEA reports to appropriate stakeholders and ensure that any new issues are captured in defect/design-related meetings.
• Review case information monthly to ensure effective closure.
• Report weekly/biweekly to the Quality Supervisor on progress.
• Undertake additional ad-hoc tasks as required.

Qualifications, Experience, Knowledge and Attributes:

• HNC in engineering, quality assurance, or a related field.
• 2+ years of experience in a Quality Engineering role, preferably in the medical device industry.
• Knowledge of ISO13485 quality management systems.
• Experience with quality control, testing procedures and quality control software/tools.
• A good understanding FMEA and RCA.
• Excellent attention to detail and accuracy.
• Commitment to high quality and continuous improvement.
• Highly organized individual.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• A flexible, can-do approach to the requirements of the job.

Job Requirements:

• Due to the nature of the role, our requirement is for this position to be Guildford based, with flexibility to work from home 2 days a week.

As a member of our highly skilled team you will receive opportunities for training and development and a competitive benefits package.

Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.

Furthermore, please be advised that if you submit an application to us for this position, your application and personal details will be processed in accordance with our Data Privacy Notice for Job Candidates.

Important notice to Employment Businesses/ Agencies:

ANGLE does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact our ANGLE recruitment team to obtain prior written authorisation before referring any candidates. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ANGLE. ANGLE shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.