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- Tasks: Conduct inspections on medical device kits and manage batch releases to ensure quality.
- Company: Yourgene Health is a global leader in clinical and pharmaceutical support services.
- Benefits: Enjoy a competitive salary, benefits package, and community initiatives for well-being.
- Why this job: Join a team that values quality and compliance while making a real impact in healthcare.
- Qualifications: Prior experience in quality assurance or inspection is preferred; attention to detail is key.
- Other info: We promote equality, diversity, and inclusion in our workforce.
The predicted salary is between 36000 - 60000 £ per year.
Quality Assurance Inspector Reports to: Senior Quality Assurance Manager
Manchester Science Park (M15 6SH)
Contract Type: Full-time, Permanent
Salary & Benefits: Competitive Salary + Benefits Package
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.
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. 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.
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.
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. 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.
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.
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.
Sunday 2nd February, 2025
Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce.
Mechanical Inspector - Quality Inspector employer: Yourgene Health
Contact Detail:
Yourgene Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Mechanical Inspector - Quality Inspector
✨Tip Number 1
Familiarize yourself with ISO13485 standards, as this role heavily involves compliance with these regulations. Understanding the nuances of these standards will not only help you in the interview but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Highlight any previous experience you have in quality assurance or inspection, especially within regulated environments. Be prepared to discuss specific examples of how you've handled non-conformances or contributed to quality improvement initiatives.
✨Tip Number 3
Showcase your attention to detail by preparing for potential scenario-based questions during the interview. Think about how you would approach a situation involving batch release documentation or a non-conformance issue.
✨Tip Number 4
Research Yourgene Health and their products, especially their medical device kits and services. Being knowledgeable about the company will allow you to ask insightful questions and demonstrate your genuine interest in the role.
We think you need these skills to ace Mechanical Inspector - Quality Inspector
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Mechanical Inspector position. Highlight key responsibilities such as conducting inspections, managing batch releases, and supporting quality systems. Tailor your application to reflect your understanding of these tasks.
Highlight Relevant Experience: In your CV and cover letter, emphasize any prior experience in quality assurance or inspection, especially within regulated environments. If you have worked with medical devices or pharmaceuticals, make sure to mention this prominently.
Showcase Attention to Detail: Since the role requires strong attention to detail, provide examples in your application that demonstrate your ability to maintain accuracy in inspections and documentation. This could include specific projects or tasks where your attention to detail made a difference.
Express Commitment to Quality: Convey your dedication to maintaining high-quality standards and compliance with regulations like ISO13485. Discuss any relevant training or initiatives you've participated in that align with continuous improvement in quality assurance.
How to prepare for a job interview at Yourgene Health
✨Understand the Role
Make sure you thoroughly understand the responsibilities of a Quality Assurance Inspector. Familiarize yourself with final inspections, batch record reviews, and ISO13485 compliance. This knowledge will help you answer questions confidently and demonstrate your suitability for the role.
✨Showcase Your Attention to Detail
Since this role requires strong attention to detail, prepare examples from your past experiences where your meticulousness made a difference. Discuss how you ensured accuracy in inspections or documentation, as this will highlight your fit for the position.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions related to non-conformance management and quality systems support. Think about how you would handle specific situations, such as identifying issues during inspections or managing corrective actions, and be ready to discuss your thought process.
✨Emphasize Team Collaboration
The role involves working closely with Quality Assurance and Production teams. Be prepared to talk about your experience in collaborative environments and how you’ve contributed to team success, especially in resolving quality-related issues.
