Quality Manager - (Maternity Leave Cover)
About Your New Employer
- Innovative Medical Device Company: Join a leading medical device engineering company that offers a range of development and manufacturing services from initial design assessment to the provision of sterile finished products for the European and US markets.
- Career Development: Work in a competitive, growing, and dynamic environment that provides opportunities for career development and employee wellness.
- Competitive Package: Enjoy a competitive employee package that includes various benefits and opportunities for professional growth.
About Your New Job
- Overall Management: Take ownership and manage the Company Quality Management System (QMS).
- Compliance: Ensure ongoing compliance with ISO 13485, FDA regulations, MDR, ISO 14971, and all applicable regulatory and customer requirements.
- Leadership: Lead, mentor, and develop the Quality team, including senior quality, quality engineers, and quality technicians.
- Quality Assurance: Ensure all products meet internal quality standards and customer/regulatory specifications.
- Audit Management: Lead all internal, customer, regulatory, and surveillance audits, including preparation, execution, and follow-up.
- CAPA and Risk Management: Drive effective CAPA, non-conformance, complaint handling, and change control processes. Ensure effective application of risk management principles in line with ISO 14971.
- Document Control: Oversee robust document control, record management, and data integrity practices.
What Skills You Need
- Educational Background: Third level qualification (Level 8 or higher) in Quality, Engineering, or a Science-based discipline.
- Experience: Minimum of 5 years in a similar position, with proven experience in the medical device industry.
- Regulatory Knowledge: Strong working knowledge of FDA regulations and ISO 13485.
- Leadership Skills: Demonstrated experience leading and developing quality teams.
- Audit and CAPA Management: Strong background in audit management and excellent understanding of CAPA, non-conformance, change control, and complaint handling systems.
- Attention to Detail: Strong attention to detail, ensuring high levels of quality at all times.
- Communication Skills: Effective communication and cross-functional collaboration skills.
- Problem-Solving: Strong strategic and problem-solving experience with the ability to multitask and prioritize workload.
- Dynamic Environment: Experience in a fast-paced, dynamic role.
What’s on Offer
- Competitive Salary: Attractive salary package.
- Professional Growth: Opportunities for training, development, and career advancement.
- Dynamic Work Environment: Be part of a collaborative and innovative team.
What’s Next
Apply now by clicking the “Apply Now" button or call Ross Keyes on 091749269 for more information. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.
