Senior Quality Engineer
About Your New Employer
- Join an innovative company renowned for excellence in regulated manufacturing environments.
- Contribute to high-impact projects supporting patient safety and product quality.
- Enjoy a collaborative culture with opportunities for professional growth and technical leadership.
About Your New Job
- As the Senior Quality Engineer, you will provide quality engineering support to manufacturing and operations, ensuring compliance with both internal and external standards.
- You will support design and development activities, including risk management, design reviews, verification/validation, and design transfer.
- You will maintain and enhance the Quality Management System (QMS), managing CAPA, NCR, Change Control, and Internal Audit programs.
- You will support supplier quality activities and oversee material qualification, supplier evaluation, and incoming inspection processes.
- You will lead investigations into root causes and ensure implementation of effective corrective and preventive actions, while also preparing and participating in regulatory and customer audits.
- You will drive continuous improvement projects to enhance process efficiency, product quality, and regulatory compliance, collaborating closely with cross-functional teams.
What Skills You Need
- Degree in Engineering, Science, or related technical discipline.
- Minimum 5 years’ experience in a Medical Device or regulated manufacturing environment.
- Strong knowledge of Quality System Regulations and Standards (ISO 13485, 21 CFR 820, ISO 14971, MDR).
- Experience in at least two of the following areas: Manufacturing Quality/Operations Support, Design Assurance/Product Development, Quality Systems Management.
- Demonstrated skill in risk management, root cause analysis, and validation methodologies.
- Excellent communication, problem-solving, and cross-functional collaboration abilities.
- Self-starter with proven experience managing multiple priorities in a dynamic environment.
What's on Offer
- Competitive salary, reflective of your experience and expertise.
- Comprehensive benefits package, ongoing training, and a clearly defined career path.
- Opportunity to play a technical lead role and influence site-wide product quality and regulatory compliance.
What's Next
Apply now by clicking the "Apply Now" button. If you would like more information or wish to discuss similar opportunities, feel free to get in touch. Multiple permanent, temporary, and contract roles are also available.
