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- Tasks: Conduct final inspections on medical device kits and manage batch releases.
- Company: Yourgene Health is a leader in genomic medicine, advancing diagnostic science globally.
- Benefits: Enjoy a competitive salary, benefits package, and a vibrant work culture.
- Why this job: Join a fast-paced, innovative team making a real impact in healthcare.
- Qualifications: Prior experience in quality assurance or related fields is preferred but not required.
- Other info: We value diversity and inclusion, ensuring everyone feels respected and valued.
The predicted salary is between 28800 - 42000 £ per year.
Job title: Quality Assurance Inspector
Reports to: Senior Quality Assurance Manager
Location: Manchester Science Park (M15 6SH)
Contract Type: Full-time, Permanent
Salary & Benefits: Competitive Salary + Benefits Package
About Yourgene Health:
Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. The group works in partnership with global leaders in DNA technology to advance diagnostic science.
Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine and infectious diseases. The Group’s flagship in vitro diagnostic products include non -invasive prenatal tests (NIPT) for Down’s Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests and DPYD genotyping.
Yourgene has a range of innovative DNA sample preparation platforms, powered by Ranger Technology, the Yourgene LightBench and Yourgene QS250, ideal for cell free DNA applications in NIPT and oncology including liquid biopsy.
Yourgene also has a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval and commercialise new products and services. In addition, Yourgene offers and NIPT and high throughput Covid testing service.
Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada.
Our Culture:
Yourgene is a growing, vibrant and exciting place to work, we are looking for committed driven individuals to be part of our next growth journey. Our culture is described by our employee’s as collegiate, friendly, professional, innovative, open and fast paced. We have nay social and well-being initiatives run by our Social Huddle that keep our sense of community alive during challenging times that the pandemic has thrown our way. At Yourgene we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey.
Description of role:
The Quality Assurance Inspector sits within the Quality Assurance department at Yourgene Health. The primary responsibilities include conducting final inspections on medical device kits and components, label inspections, batch record review, and managing batch release. The role also involves handling issues or non-conformances related to inspections or batch releases, as well as supporting other quality system duties as required. This role is vital in maintaining product quality and ensuring compliance with ISO13485 and other applicable regulatory standards.
Overall responsibility:
The primary responsibility of this role is inspection and release of materials, labels, and components to ensure customer availability. Some involvement in ISO13485 Quality Systems maintenance will also be required.
Key areas of responsibility:
- Final Inspection – Perform detailed visual inspections of medical device kits, components, and labels to verify conformance to specifications and standards.
- Batch Record Review – Review batch records for accuracy, completeness, and compliance with standard operating procedures (SOPs) and regulatory requirements. Document and report any discrepancies, deviations, or non-conformances observed during the review process.
- Batch Release – Complete batch release documentation based on final inspection results and batch record review. Coordinate batch release activities to meet product availability timelines while ensuring adherence to quality standards.
- Issue and Non-Conformance Management – Identify and document issues or non-conformances related to final inspections and batch releases. Work with Quality Assurance and Production teams to investigate root causes, implement corrective actions, and follow up on issue resolution.
- Quality Systems Support – Assist in quality system duties as required, such as document control, training, and participation in quality audits. Support continuous improvement initiatives within the Quality Assurance department.
Qualifications, Skills and Abilities:
- Prior experience in quality assurance, inspection, or a related field within a regulated environment. Direct experience in medical devices or pharmaceuticals, is preferred but not required.
- Basic understanding of ISO13485, ISO9001 or other management system standard
- Experience with management of quality system records (Nonconformance, Corrective Actions)
- Strong attention to detail to ensure accuracy in inspection, labeling, and documentation.
- Ability to manage multiple tasks efficiently and maintain accurate records for batch release and inspections.
- Good communication to aid collaboration with other teams
Closing Date:
Sunday 2nd February, 2025
Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce. The aim is for our workforce to be truly representative of all sections of society and for each employee to feel respected and able to give their best.
Quality Assurance Inspector employer: Yourgene Health
Contact Detail:
Yourgene Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Inspector
✨Tip Number 1
Familiarize yourself with ISO13485 and other relevant regulatory standards. Understanding these standards will not only help you in the interview but also demonstrate your commitment to quality assurance in the medical device industry.
✨Tip Number 2
Highlight any previous experience you have in quality assurance or inspection, especially within regulated environments. Be ready to discuss specific examples of how you've ensured compliance and maintained product quality.
✨Tip Number 3
Prepare to showcase your attention to detail. Since the role involves detailed inspections and batch record reviews, think of instances where your meticulous nature has positively impacted a project or process.
✨Tip Number 4
Demonstrate your ability to work collaboratively with other teams. Quality assurance often requires communication and teamwork, so be prepared to share examples of how you've successfully collaborated in past roles.
We think you need these skills to ace Quality Assurance Inspector
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Quality Assurance Inspector at Yourgene Health. Familiarize yourself with key areas such as final inspections, batch record reviews, and compliance with ISO13485 standards.
Tailor Your CV: Customize your CV to highlight relevant experience in quality assurance or inspection, especially within regulated environments. Emphasize any direct experience with medical devices or pharmaceuticals, as well as your understanding of quality management systems.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for quality assurance and your alignment with Yourgene's values. Mention specific skills that relate to the job description, such as attention to detail and effective communication.
Proofread Your Application: Before submitting your application, carefully proofread all documents to ensure there are no errors. A polished application reflects your attention to detail, which is crucial for a role in quality assurance.
How to prepare for a job interview at Yourgene Health
✨Understand ISO Standards
Familiarize yourself with ISO13485 and other relevant standards. Be prepared to discuss how these standards apply to quality assurance in the medical device industry, as this knowledge will demonstrate your commitment to compliance and quality.
✨Showcase Attention to Detail
During the interview, provide examples of how you've ensured accuracy in past inspections or quality assurance tasks. Highlight specific instances where your attention to detail made a significant impact on product quality.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills, especially regarding non-conformances or discrepancies. Think of scenarios from your previous experience where you identified issues and implemented corrective actions.
✨Communicate Effectively
Demonstrate your communication skills by articulating your thoughts clearly and concisely. Discuss how you have collaborated with cross-functional teams in the past to resolve quality issues, as teamwork is crucial in this role.
