At a Glance
- Tasks: Ensure quality standards are met and improve processes in a dynamic environment.
- Company: Join a leading company in the medical device industry with a focus on quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Be part of a supportive team dedicated to excellence and innovation.
- Why this job: Make a real impact on product quality and compliance while developing your skills.
- Qualifications: Experience in quality assurance and knowledge of ISO13485 required.
The predicted salary is between 35000 - 45000 £ per year.
Aim of Role:
- To coordinate the activities required to ensure all statutory and internal quality procedures and policies adhere to the company’s quality management systems and that they are continually being improved.
- Provide internal audit support & drive improvements in processes.
- Writing procedures and identifying gaps in existing QMS.
- Provide quality and compliance support and administration service for the effective functioning of the quality management system and provide guidance to others if required.
Customer Responsibilities:
- Co-ordinate the documentation and the follow up investigations leading to closure of active Non-Conformities and Distributor/customer complaints (and associated CAPAs).
- Review and investigate customer complaints and non-conformities and ensure timely close out.
Quality Responsibilities:
- Provide Quality and compliance support and administrative service for the effective functioning of the Quality Management System and provide guidance to others if required.
- Run internal audit program including in-process audits.
- Develop and maintenance of all quality assurance procedures and policies to ensure that legal and accreditation requirements are met, in line with rules and guidance for Medical Device manufacturers and accreditation bodies (MHRA, EN ISO13485, ISO9001).
- Perform a non-technical review and make non-technical corrections on the electronic quality system documentation.
- Provide documentation control assistance to manufacturing as appropriate.
- Coordinate the actions agreed in internal and regulatory bodies audit reports.
- Assist with the maintenance of the electronic QM System, including monitoring progression of open projects and providing full assistance in achieving closure on time.
- Ensure all routine checks on calibration, equipment and services are being performed.
- Monitor equipment effectiveness and associated communicate costs.
- Maintain approved suppliers and contractors lists and associated risk assessments.
- Ensuring artwork and literature meet regulatory and customer needs.
- Provide/review regular progress report of outstanding complaints, CAPA and non-conformances. Provide assistance in analyzing trends of complaints by category and help in investigations.
- Support/provide any practical training required in support of agreed actions.
Regulatory Responsibilities:
- Part of the Person(s) Responsible Team for official communication and regulatory compliance.
Other Duties:
- Deal with basic manufacturing issues as required.
- Understanding of product characteristics and product mix.
Health and Safety Responsibilities:
- Responsible for reporting health and safety issues seen to Managing Director.
- Responsible for observing the company health and safety policy.
Experience:
- Previous experience in a similar role is essential.
- Experience of working with Medical Devices and/or ISO13485 is required.
Salary is according to experience.
Please note that due to volume of applications, only shortlisted candidates will be contacted.
Quality Assurance Specialist employer: East Lancashire Services
As a Quality Assurance Specialist at our company, you will thrive in a dynamic work environment that prioritises quality and compliance while fostering continuous improvement. We offer a supportive culture that encourages professional growth through training and development opportunities, alongside competitive benefits tailored to enhance your work-life balance. Located in a vibrant area, our company is committed to maintaining high standards in the medical device industry, making it an excellent place for those seeking meaningful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its quality management systems. Be ready to discuss how your experience aligns with their needs, especially around ISO13485 and medical devices.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, share specific examples of how you've tackled non-conformities or improved processes in previous roles. This will demonstrate your value as a Quality Assurance Specialist.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance Specialist role. Highlight your experience with quality management systems and any relevant certifications, especially in ISO13485. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our team. Be specific about your past experiences and how they relate to the responsibilities listed in the job description.
Showcase Your Problem-Solving Skills:In your application, don’t forget to mention instances where you've successfully identified gaps in processes or improved quality procedures. We love candidates who can demonstrate their analytical skills and proactive approach to problem-solving!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of being noticed. It’s the easiest way for us to keep track of your application and ensure it gets to the right people. Plus, we love seeing applications come in through our own platform!
How to prepare for a job interview at East Lancashire Services
✨Know Your Quality Management Systems
Familiarise yourself with the key quality management systems relevant to the role, such as ISO13485 and ISO9001. Be prepared to discuss how you've applied these standards in your previous roles and any improvements you've driven in quality processes.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to describe how you would handle specific situations, like dealing with non-conformities or customer complaints. Think of examples from your past experience where you successfully resolved similar issues and be ready to share those stories.
✨Showcase Your Audit Experience
Since the role involves running internal audits, be ready to talk about your experience with auditing processes. Highlight any specific audits you've conducted, the outcomes, and how you used those findings to improve quality management systems.
✨Demonstrate Your Communication Skills
As a Quality Assurance Specialist, you'll need to communicate effectively with various stakeholders. Prepare to discuss how you've provided guidance and support to others in your previous roles, and be ready to showcase your ability to convey complex information clearly.
