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- Tasks: Lead quality control systems and ensure compliance with industry standards in medical devices.
- Company: Dynamic medical device company focused on innovation and quality.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Join a team dedicated to continuous improvement and excellence in medical device manufacturing.
- Why this job: Make a real difference in healthcare by ensuring product quality and safety.
- Qualifications: Experience in quality management and knowledge of ISO standards required.
The predicted salary is between 45000 - 55000 £ per year.
Develops, implements and maintains the activities of quality control systems. Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Develops budget and monitors expenditures. Ensures all aspects of ISO13485, relevant standards and applicable regulatory requirements are met and upheld within the QMS and the Organisation.
Makes recommendations for corrective action necessary to ensure conformity with quality specifications. Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations. Selects, develops and evaluates personnel to ensure the efficient operation of the function. First level of managerial position. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Works on issues of a diverse scope where analysis of situation or data requires evaluation of a variety of factors. Typically manages a department of Professional track employees but may also have support track direct or indirect reports.
Duties & Responsibilities
- Ownership & management of customer complaints investigations (CAPA) with focus on preventive actions implementation and their effectiveness verification; preparation, analysis & distribution of associated KPI metrics
- Active participation in continuous improvement and maintenance of company’s integrated QEHSMS accredited to ISO13485/9001/14001/45001 with the emphasis on medical devices manufacturing compliance – development, review & update of relevant QEHSMS documentation; internal audits etc.
- Active participation in suppliers quality management – review & approval process; supplier audits; purchased product control plans preparation, review and approval
- Risk management oversight: preparation of process FMEAs, manufacturing process verification & validation management
- Participation in Optical Measuring System programming for inspections of purchased product (training provision to be given)
- Quality Engineering support as part of day-to-day business as well as part of the cross-functional teams for continuous improvement activities
- Any other duties and responsibilities as required
Technical Requirements
- Working Knowledge of ISO13485/9001/14001/45001 with the emphasis on medical devices manufacturing compliance – development
- Workplace Health and Safety Legislation
- Practical knowledge of EU MDR
- Six Sigma
Quality Assurance Manager in Norwich employer: Wynne Consulting
Contact Detail:
Wynne Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager in Norwich
✨Tip Number 1
Network like a pro! Reach out to people in the medical devices industry, especially those who work in quality assurance. Use platforms like LinkedIn to connect and engage with them. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on ISO standards and quality management systems. Be ready to discuss your experience with CAPA and continuous improvement initiatives. Show us you know your stuff, and you'll stand out from the crowd!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise in medical devices. Tailor your approach to each company’s culture and mission. We want to see your passion for quality assurance shine through!
✨Tip Number 4
Finally, 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 that Quality Assurance Manager role!
We think you need these skills to ace Quality Assurance Manager in Norwich
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance Manager role. Highlight your experience with ISO standards and any relevant quality control systems you've worked with. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in medical devices. Share specific examples of how you've tackled challenges in previous roles, especially around CAPA and continuous improvement.
Showcase Your Achievements: Don't just list your responsibilities; showcase your achievements! Quantify your successes where possible, like improvements in quality metrics or successful audits. We love seeing how you've made a difference in your past roles.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It helps us keep track of applications and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Wynne Consulting
✨Know Your Standards
Make sure you brush up on ISO13485 and other relevant standards before the interview. Being able to discuss how you've implemented these in past roles will show your expertise and commitment to quality management.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've handled customer complaints or CAPA investigations. Highlight your approach to preventive actions and how you verified their effectiveness, as this is crucial for the role.
✨Demonstrate Continuous Improvement Mindset
Be ready to talk about your experience with continuous improvement initiatives. Discuss specific projects where you contributed to enhancing quality systems or processes, especially in a medical devices context.
✨Engage with Technical Knowledge
Familiarise yourself with the technical requirements mentioned in the job description, like FMEAs and risk management. Showing that you can engage with these concepts will set you apart as a strong candidate.