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- Tasks: Lead quality control systems and ensure compliance with medical device standards.
- Company: Dynamic medical devices 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 - 60000 £ per year.
QUALITY MANAGER - MEDICAL DEVICES
LOCATION: EAST ANGLIA - HYBRID
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
QA Lead (Electrical) in Diss employer: Wynne Consulting
Contact Detail:
Wynne Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Lead (Electrical) in Diss
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical devices field and let them know you're on the hunt for a QA Lead role. 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 brushing up on ISO13485 and other relevant standards. We recommend creating a cheat sheet of key points and examples from your past experiences that showcase your expertise in quality management and compliance.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you, and tailor your approach to each company’s culture and mission.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to show your genuine interest in the role and the company.
We think you need these skills to ace QA Lead (Electrical) in Diss
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA Lead role. Highlight your experience with ISO standards and quality management systems, as these are key for us. Use specific examples that showcase your skills in managing customer complaints and continuous improvement.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Tell us why you're passionate about quality management in medical devices. Mention any relevant projects or achievements that align with our focus on compliance and quality assurance.
Showcase Your Technical Knowledge: We love candidates who know their stuff! Make sure to mention your working knowledge of ISO13485 and other relevant standards. If you have experience with risk management or Six Sigma, don’t forget to include that too!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen to join our team!
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 and 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 any 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. Be prepared to discuss how these regulations impact quality management and how you've navigated them in your previous roles.