Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead quality engineering activities and manage customer complaints for top-notch post-market experiences.
- Company: Join Flexicare, a global leader in medical devices with over 35 years of experience.
- Benefits: Enjoy competitive salary, pension, performance bonuses, and 33 days of holiday per year.
- Why this job: Be part of a growing company that values innovation and quality in patient care.
- Qualifications: Requires Level 6 qualification in science or engineering and 5+ years of relevant experience.
- Other info: Applications close on Friday 7th March 2025.
The predicted salary is between 36000 - 60000 £ per year.
Senior Quality Engineer – Customer Quality
With over 35 years of experience, Flexicare is a leading designer and global provider of medical devices that enhance patient care. Headquartered in the UK, we support clinicians worldwide with class-leading devices and a global network of subsidiaries across over 100 countries. Flexicare has ambitious plans for international growth and we want you to be a part of our journey!
What You’ll Do
- Lead process to support products in customer experience post market, including complaint investigation, corrective action, preventive action, FSN, vigilance and post market surveillance
- Lead the development of new systems and procedures
- Plan, conduct and supervise closure of complaints, FSN, vigilance reports
- Drive KPI delivery in complaint process
- Actively support team development within quality to increase performance and engagement
- Support CAPA and NC initiation and execution
- Work closely with design, operations and other business functions to ensure quality performance of products
- Work closely with customers, sales/marketing/field personnel and cross-functional teams to address top quality issues
- Maintain KPI’s for monitoring of process and/or product quality, perform analysis and interpret trends and take action as necessary
- Advocate of Human Factor practices, familiarity in the science of Human Factor Identification, reduction and mitigation
- Develop understanding of risk management practices and concepts
- Develop proficiency in statistical methods and application
- Engage and interface in internal audits providing effective narrative and description of the topic expertise, participate in external audit preparation building confidence and proficiency in interactions
- Responsible for the initiation, internal containment and support of ship and product holds for potential product escapes
- Ensure device traceability of returns
Who You Are
We believe you’re the right fit if you have
- Level 6 qualification in a science, engineering or related Advanced degree preferred
- Master’s degree or equivalent
- Minimum 5 years experience
- Demonstrated knowledge and application of regulatory requirements, including ISO, FDA and International requirements
- Demonstrated technical knowledge of medical device product lines
- Knowledge of adverse event reporting, complaint investigation, CAPA and corrective action processes
What You’ll Get
- Competitive Salary in accordance with experience and capabilities
- Pension
- Company performance bonus (paid annually)
- 33 days Holiday per year (incl Bank Holidays) plus Holiday Trading Scheme
- Benefits package: Life Assurance (x2), Income protection (50% of salary), Health Cashplan (Medicash), Benefit pot – for spending on additional benefits, which include: Upgrade Health Cash plan, Critical Illness cover, Cycle to work, Tech Benefits, Will Writing, Or add it to your pension pot if not used.
Applications close on Friday 7th March 2025
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Senior Quality Engineer - Customer Quality employer: Flexicare (Group) Limited
Contact Detail:
Flexicare (Group) Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Engineer - Customer Quality
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements mentioned in the job description, such as ISO and FDA standards. This knowledge will not only help you during the interview but also demonstrate your commitment to quality engineering in the medical device industry.
✨Tip Number 2
Highlight your experience with complaint handling and post-market activities in your discussions. Be prepared to share specific examples of how you've successfully managed complaints and implemented corrective actions in previous roles.
✨Tip Number 3
Showcase your leadership skills by discussing any team development initiatives you've led. Emphasize how you've engaged and motivated teams to improve performance and achieve quality objectives.
✨Tip Number 4
Prepare to discuss your proficiency in statistical methods and risk management practices. Being able to articulate how you've applied these skills in real-world scenarios will set you apart from other candidates.
We think you need these skills to ace Senior Quality Engineer - Customer Quality
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Senior Quality Engineer position. Make sure you understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in quality engineering, particularly in complaint handling and post-market activities. Use specific examples that demonstrate your leadership skills and technical knowledge of medical devices.
Showcase Your Skills: Make sure to highlight your familiarity with regulatory requirements such as ISO and FDA standards. Discuss your experience with CAPA processes and your ability to drive continuous improvement initiatives.
Craft a Compelling Cover Letter: Write a personalized cover letter that connects your background and skills to the specific needs of Flexicare. Mention your passion for enhancing patient care and how you can contribute to their ambitious growth plans.
How to prepare for a job interview at Flexicare (Group) Limited
✨Understand the Regulatory Landscape
Familiarize yourself with ISO, FDA, and international regulatory requirements relevant to medical devices. Be prepared to discuss how your experience aligns with these standards and how you can ensure compliance in your role.
✨Showcase Your Leadership Skills
Highlight your leadership experience, especially in managing quality engineering activities and team development. Provide examples of how you've successfully led teams to improve performance and engagement in previous roles.
✨Prepare for Technical Questions
Expect questions related to complaint handling, CAPA processes, and statistical methods. Brush up on your technical knowledge of medical device product lines and be ready to discuss specific scenarios where you've applied this knowledge.
✨Demonstrate Your Problem-Solving Abilities
Be prepared to discuss how you've approached complex quality issues in the past. Use the STAR method (Situation, Task, Action, Result) to structure your responses and showcase your analytical skills in identifying trends and implementing corrective actions.
