Join Our Team as a Quality Engineer at Del Medical!
About Us: At Del Medical, we’re trailblazers in medical imaging solutions, committed to improving healthcare outcomes with top-tier products. As leaders in the medical device industry, we pride ourselves on quality, innovation, and safety. We are looking for a Quality Engineer to become an integral part of our team and help ensure that every product we deliver meets the highest standards.
Position Overview: The Quality Engineer will support our Quality Assurance team by maintaining robust processes that ensure regulatory compliance and top-notch product quality. This role offers an excellent opportunity to grow your expertise in medical device design and manufacturing while driving continuous improvement across our operations. Our team has decades worth of experience to help you on your career journey. Come and explore why our company is growing and expanding.
Key Responsibilities:
- Lead internal and external audits to comply with ISO 13485, MDSAP, and FDA regulations.
- Support the CAPA process by identifying root causes and implementing corrective measures.
- Partner with cross-functional teams to implement process improvements and boost product quality.
- Continuously identify and lead initiatives to enhance quality, efficiency, and reliability.
- Analyze quality data, track trends, and present opportunities for process improvements.
- Prepare quality reports and present findings to management for informed decision-making.
- Monitor and help achieve quality performance indicators (KPIs).
- Participate in lean manufacturing projects to reduce waste and boost production efficiency.
- Innovate and propose improvements to quality systems and processes.
- Manage supplier corrective actions and maintain detailed supplier quality records.
- Train team members on quality standards and best practices, ensuring a strong culture of quality across departments.
- Collaborate with other departments to embed quality assurance in every aspect of production.
- Maintain regulatory submissions, compliance files, and product labeling to ensure alignment with ISO 13485, Part 820, and MDSAP.
- Support the management of the Quality Management System (QMS) and ensure it remains audit ready.
- Work with engineering and manufacturing teams to implement regulatory requirements during product development and production.
- Support design reviews, risk assessments, and validation/verification activities.
- Stay up-to-date with regulatory changes and provide insights on emerging trends in medical device regulations.
- Assist in ensuring product compliance through post-market surveillance and vigilance reporting.
Qualifications:
- Bachelor’s degree or diploma in Science, Engineering, Quality or similar discipline
- 2 years of experience in Engineering, Manufacturing Engineering or similar. Preferably in a regulated environment, such as medical devices, healthcare or the aerospace industry.
- Strong attention to detail and the ability to manage quality documents.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Ability to work in a fast-paced environment and collaborate with cross-functional teams.
Desired Qualifications:
- Strong understanding of medical device regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO9001 and global regulatory pathways.
- Solid understanding of quality tools such as FMEA, Root Cause Analysis, and Lean Six Sigma.
- Familiarity with the 510(k) process and CE Marking.
Why Join Us? At Del Medical, you’ll be part of a dynamic team dedicated to innovation in healthcare. We offer a supportive environment where your ideas can shape the future of medical imaging, and your contributions will make a meaningful impact on global healthcare standards.
