At a Glance
- Tasks: Ensure compliance in Quality Assurance and Regulatory Affairs for medical devices.
- Company: Leading supplier of high-quality medical and surgical devices.
- Benefits: Competitive pay, profit share, health cover, hybrid work, and professional growth.
- Why this job: Make a real impact in quality management while enhancing your leadership skills.
- Qualifications: Experience in QA within medical devices and knowledge of relevant standards.
- Other info: Dynamic environment with opportunities for career advancement.
The predicted salary is between 36000 - 60000 £ per year.
iRecruit4 are currently seeking a highly organised and detail-oriented Senior Quality Compliance Officer. In this key role, you will take responsibility and play an active part in ensuring that the Quality Assurance and Regulatory Affairs tools and processes support a fully compliant Product and Quality Management System. If you have a strong background in QA/RA, exceptional attention to detail, and a passion for upholding the highest quality standards, we'd love to hear from you.
Benefits:
- Competitive Pay and Profit Share
- Health & Wellness - critical illness cover, private healthcare
- Discounts on retail
- Hybrid - once probation is passed
- Full training given
- Professional Growth
- Birthdays off
- Company pension
- Opportunity to deputise for senior management, enhancing leadership skills
About the Role:
Step into a pivotal role within a leading supplier of medical and surgical devices, renowned for delivering high-quality products and exceptional customer service. This position offers a dynamic environment where your expertise in Quality Assurance and Regulatory Affairs will be instrumental in maintaining a compliant Products and Quality Management System.
Key Responsibilities:
- Promote compliance with Company and Regulatory requirements, ensuring proprietary information protection.
- Record and investigate Non-conformances (NCs) and Corrective and Preventive Actions (CAPAs) using root cause analysis tools.
- Manage NC and CAPA processes, including regular KPI reporting.
- Deputise for the QA/RA Manager & Responsible Person (RP) as needed.
- Support the implementation and maintenance of a Quality Management System (QMS), including quality risk management, documentation management, and internal audits.
- Review documentation for accuracy and compliance with cGDP and MDD/MDR.
- Support the supplier assurance programme and the Labour Standards Assurance Scheme (LSAS).
- Participate in regulatory and customer audits, and maintain knowledge of site policies and procedures.
Candidate Profile:
- Proven experience in a Quality Assurance role within the medical device or pharmaceutical industry.
- Qualified Internal Auditor with a thorough understanding of ISO13485, ISO9001, MDD/MDR, GDP, ISO27001, and LSAS requirements.
- Proficient in Windows applications (Word, Excel, etc.).
- Strong interpersonal skills with the ability to challenge behaviours appropriately.
- Excellent time management and the ability to work under pressure with a flexible attitude.
- Capable of analysing data and generating comprehensive reports.
- Effective communication skills, both oral and written.
- Ability to work independently and as part of a team, liaising confidently with staff, suppliers, and customers at all levels.
This role is ideal for a motivated professional looking to make a significant impact within a reputable company. If you possess the required skills and experience, this could be the next step in your career.
Senior Quality Compliance Officer in Swindon employer: iRecruit4
Contact Detail:
iRecruit4 Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Compliance Officer in Swindon
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their quality compliance processes and be ready to discuss how your experience aligns with their needs. We want you to shine and show them why you’re the perfect fit!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to build your confidence. We can’t stress enough how important it is to articulate your skills and experiences clearly, especially in a technical field like Quality Assurance.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us. Let’s get you on board!
We think you need these skills to ace Senior Quality Compliance Officer in Swindon
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experience mentioned in the job description. Highlight your QA/RA background and any relevant certifications to catch our eye!
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about quality compliance. Share specific examples of how you've upheld high standards in previous roles to show us what you can bring to the table.
Showcase Your Attention to Detail: Since this role requires exceptional attention to detail, ensure your application is free from typos and errors. A polished application demonstrates your commitment to quality right from the start!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates!
How to prepare for a job interview at iRecruit4
✨Know Your Regulations
Make sure you brush up on the key regulations and standards relevant to the role, like ISO13485 and MDD/MDR. Being able to discuss these confidently will show that you’re not just familiar with them, but that you can apply them in practice.
✨Showcase Your Attention to Detail
Prepare examples from your past experience where your attention to detail made a difference. Whether it’s catching a non-conformance or improving a process, having specific stories ready will highlight your strengths in this area.
✨Demonstrate Your Problem-Solving Skills
Be ready to discuss how you've handled Non-conformances and CAPAs in the past. Use the STAR method (Situation, Task, Action, Result) to structure your answers and illustrate your analytical skills and ability to implement corrective actions.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s Quality Management System and their approach to compliance. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.