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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 supportive team dedicated to continuous improvement and excellence.
- 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 50000 - 65000 £ 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.
Locations
Quality Assurance Manager in Diss, Norfolk employer: Wynne Consulting
Contact Detail:
Wynne Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager in Diss, Norfolk
✨Tip Number 1
Network like a pro! Reach out to people in the medical devices industry, especially those who work in quality assurance. Attend industry events or webinars, and don’t be shy about asking for informational interviews. You never know who might have a lead on your dream job!
✨Tip Number 2
Show off your skills! Prepare a portfolio that highlights your experience with ISO standards and quality management systems. Use real examples of how you've improved processes or solved problems in previous roles. This will give you an edge during interviews.
✨Tip Number 3
Practice makes perfect! Get ready for interviews by doing mock sessions with friends or mentors. Focus on common questions related to quality assurance and medical device compliance. The more comfortable you are, the better you'll perform when it counts.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you. Tailor your application to highlight your experience with CAPA and continuous improvement. Let’s get you into a role where you can make a real impact!
We think you need these skills to ace Quality Assurance Manager in Diss, Norfolk
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 improved processes or handled customer complaints – we love a good success story!
Showcase Your Technical Knowledge: Don’t forget to mention your working knowledge of ISO13485 and other relevant standards. We’re keen on candidates who understand the ins and outs of quality management systems, so make sure to highlight your expertise in this area.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to upload your tailored CV and cover letter directly. Let’s get your application in!
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 workplace health and safety legislation and EU MDR. Showing that you understand these regulations will set you apart and demonstrate your readiness for the challenges of the role.