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- Tasks: Lead quality management for a medical device company and oversee a dedicated QA/QC team.
- Company: Join a reputable medical device company in South Wales focused on quality and compliance.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Make a real impact on healthcare by ensuring top-notch quality standards in medical devices.
- Qualifications: Must have a degree and extensive experience in medical device quality systems and leadership.
- Other info: Be the key player in maintaining compliance with ISO and FDA regulations.
The predicted salary is between 43200 - 72000 £ per year.
Quality Manager – South Wales – Medical
About the Company:
We are looking for an experienced Quality Manager to oversee quality at a medical device company based in South Wales. As well as being responsible for quality on site you will manage an established team of QA and QC staff.
Responsibilities:
- Ensuring compliance with ISO 13485, EU MDR, UK MDR and FDA requirements.
- Managing the Quality Management System.
- Managing the quality department.
- Providing quality support to manufacturing.
- Leading and managing quality projects.
- Acting as the company representative for quality.
- Maintaining key quality systems including CAPA, complaints management and sterilization.
- Data analysis.
- Ensuring that quality is seen as an essential part of the work for all departments.
- Acting as the site lead for external audits.
- Leading internal audits.
- Collaborating with departmental heads regarding quality training.
- Preparing and delivering management presentations for the quality department.
Requirements:
- Excellent knowledge of medical device quality systems including ISO13485, 21 CFR Part 807, EU MDR and UK MDR.
- Educated to degree level.
- Substantial experience in a leadership or senior role within a quality department and team.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing and Hospitals and Health Care
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General Manager Quality employer: Kinetica
Contact Detail:
Kinetica Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land General Manager Quality
✨Tip Number 1
Familiarize yourself with the latest updates on ISO 13485, EU MDR, and UK MDR regulations. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to quality management in the medical device industry.
✨Tip Number 2
Highlight your leadership experience by preparing specific examples of how you've successfully managed teams in previous roles. Discussing your approach to team dynamics and conflict resolution can set you apart as a strong candidate for the General Manager Quality position.
✨Tip Number 3
Showcase your data analysis skills by discussing relevant projects where you utilized data to drive quality improvements. This will illustrate your analytical mindset and ability to make informed decisions based on quality metrics.
✨Tip Number 4
Prepare to discuss your experience with external and internal audits. Being able to articulate your role in these processes and how you ensured compliance will demonstrate your thorough understanding of quality systems and your capability to lead in this area.
We think you need these skills to ace General Manager Quality
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the General Manager Quality position. Understand the key responsibilities and requirements, especially regarding compliance with ISO 13485 and other regulations.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in managing quality systems and leading teams. Provide specific examples of how you've ensured compliance with medical device regulations in previous roles.
Showcase Leadership Skills: Since this role requires substantial experience in a leadership position, be sure to highlight your leadership skills. Discuss your experience in managing teams, leading projects, and collaborating with other departments.
Tailor Your Application: Customize your application materials to reflect the language and priorities mentioned in the job description. Use keywords related to quality management and medical devices to make your application stand out.
How to prepare for a job interview at Kinetica
✨Showcase Your Knowledge of Quality Standards
Make sure to highlight your understanding of ISO 13485, EU MDR, UK MDR, and FDA requirements during the interview. Be prepared to discuss how you've implemented these standards in previous roles.
✨Demonstrate Leadership Experience
Since the role involves managing a team, share specific examples of how you've successfully led quality teams in the past. Discuss your approach to motivating staff and driving quality initiatives.
✨Prepare for Technical Questions
Expect technical questions related to quality management systems and data analysis. Brush up on your knowledge of CAPA, complaints management, and sterilization processes to confidently answer these queries.
✨Emphasize Collaboration Skills
Quality is a cross-departmental responsibility. Be ready to talk about how you've collaborated with other departments to enhance quality training and ensure compliance across the board.
