At a Glance
- Tasks: Lead PFMEA activities and ensure compliance in manufacturing processes.
- Company: Join a leading medical device company focused on quality and innovation.
- Benefits: Competitive salary, career development, and a supportive work environment.
- Other info: Collaborative culture with opportunities for growth and learning.
- Why this job: Make a real impact on product quality and safety in healthcare.
- Qualifications: Bachelor’s degree in Engineering or Quality; experience in PFMEA and regulatory standards.
The predicted salary is between 50000 - 65000 € per year.
We are seeking a PFMEA/ Quality Lead who is responsible for ensuring robust, compliant, and risk‑based process control across all manufacturing and engineering change activities. The role leads PFMEA processes, ensures documentation meets regulatory and internal standards, collaborates with cross‑functional teams, oversees change control evidence, validates production processes, and drives continuous improvement in operational quality.
Key Responsibilities
- Lead, facilitate, and maintain PFMEA activities for new and existing manufacturing processes.
- Maintain high standards of communication with stakeholders and ensure timely delivery of PFMEA activities.
- Ensure PFMEAs comply with ISO 14971, ISO 13485, FDA 21 CFR Part 820, and internal QMS/risk‑management procedures.
- Validate process changes by reviewing evidence, guiding teams, and writing high‑quality technical reports to support change orders and support process readiness and product launch activities.
- Support development and maintenance of Control Plans, Process Flow Diagrams, and Work Instructions.
- Approve the Device Master Record revisions and ensure documentation accuracy.
- Support internal and supplier quality audits and support regulatory inspections.
- Review and implement engineering, design, and documentation changes impacting production.
- Maintain and improve QMS procedures and ensure regulatory alignment.
- Partner with Manufacturing Engineering to define and validate process controls using statistical tools (MSA, SPC, capability studies).
- Drive improvements to reduce variation and strengthen process capability.
- Contribute to root‑cause investigations, risk‑based decision‑making, and CAPA activities.
- Provide line management, coaching, and development for quality personnel in the production environment.
- Guide cross‑functional teams in gathering correct and supporting evidence for PFMEA and change orders and quality best practices.
- Coordinate with manufacturing teams to ensure quality standards are met through all stages of production.
- Perform additional reasonable duties aligned with role scope and organisational needs.
Skills
- Medical devices preferred.
- Experience in equipment and process validation, including IQ, OQ, PQ activities.
- Strong background in PFMEA methodology, Quality, Process Engineering, or Manufacturing Engineering and process risk management.
- Solid understanding of medical device regulations (ISO 13485, ISO 14971, FDA QMSR).
- Experience in conducting internal and supplier audits.
- Strong analytical and problem‑solving skills, using data and structured thinking to resolve issues.
- Ability to review engineering drawings, specifications, and process documentation.
- Proficiency in PFMEA software/tools.
- Experience with statistical methods such as MSA, SPC, and capability analysis.
- Strong facilitation, communication, and cross‑functional collaboration skills.
- Structured problem‑solving experience (8D, DMAIC, Fishbone).
- Bachelor’s degree in Engineering, Quality, or a related technical field.
Manufacturing Quality Manager (PFMEA) in Hampshire employer: Vision RT Ltd
As a leading employer in the medical device sector, we pride ourselves on fostering a collaborative and innovative work culture that prioritises quality and compliance. Our Manufacturing Quality Manager role offers exceptional opportunities for professional growth, with access to continuous training and development while working alongside cross-functional teams dedicated to excellence. Located in a dynamic environment, we provide a supportive atmosphere where your contributions directly impact product quality and patient safety.
StudySmarter Expert Advice🤫
We think this is how you could land Manufacturing Quality Manager (PFMEA) in Hampshire
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. 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 researching the company and its culture. Understand their products and processes, especially around PFMEA and quality management. This will help you tailor your answers and show you're genuinely interested.
✨Tip Number 3
Practice your responses to common interview questions, but keep it natural. Use the STAR method (Situation, Task, Action, Result) to structure your answers, especially when discussing your experience with quality processes and risk management.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression and shows your enthusiasm for the role. And remember, check out our website for more opportunities that match your skills!
We think you need these skills to ace Manufacturing Quality Manager (PFMEA) in Hampshire
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Manufacturing Quality Manager role. Highlight your experience with PFMEA, quality management systems, and any relevant regulatory knowledge. We want to see how your skills align with 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 management in manufacturing and how your background makes you a great fit for our team. Keep it engaging and relevant to the job description.
Showcase Your Achievements:When detailing your experience, focus on specific achievements that demonstrate your expertise in process validation, risk management, and continuous improvement. Numbers and outcomes speak volumes, so don’t shy away from sharing those!
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 you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Vision RT Ltd
✨Know Your PFMEA Inside Out
Make sure you’re well-versed in PFMEA methodology and can discuss its application in manufacturing processes. Be ready to share examples of how you've led PFMEA activities and ensured compliance with standards like ISO 14971 and FDA regulations.
✨Showcase Your Communication Skills
Since the role involves high levels of collaboration, practice articulating your thoughts clearly. Prepare to discuss how you've maintained communication with stakeholders and facilitated cross-functional teams in past projects.
✨Prepare for Technical Questions
Brush up on your knowledge of process validation, statistical methods, and quality management systems. Expect questions that test your understanding of MSA, SPC, and how you’ve used these tools to drive improvements in operational quality.
✨Demonstrate Problem-Solving Abilities
Be ready to tackle hypothetical scenarios or case studies during the interview. Use structured problem-solving techniques like DMAIC or Fishbone to showcase your analytical skills and how you approach root-cause investigations.
