Quality Engineer chez DEL MEDICAL INC

Description

At Del Medical, we are pioneers in providing cutting-edge medical imaging solutions. Our mission is to deliver the highest quality products that improve healthcare outcomes. We're looking for a passionate and driven Quality Engineer to join our team and help ensure that our products meet the highest standards of quality and safety in the medical device industry.

Position Overview:

As a Quality Engineer, you will play a critical role in supporting the quality assurance team by maintaining our high standards in product quality and regulatory compliance. You will assist with quality control processes, participate in audits, and help drive continuous improvement in our production operations. This role offers a unique opportunity to grow and develop your skills within a collaborative and dynamic environment.

• Process & Product Audits:
  • Participate in internal and external audits to ensure compliance with industry standards such as ISO 13485, MDSAP and FDA regulations.
  • Support the Corrective and Preventive Actions (CAPA) process by identifying root and helping to implement corrective measures.
  • Collaborate with cross-functional teams to ensure process improvements are implemented effectively.
  • Identify opportunities for process improvements and drive initiatives to enhance product quality, efficiency and reliability.
• Data Analysis & Reporting:
  • Collect and analyze quality data to identify trends related to customer complaints, non-conformities, etc. and opportunities for process improvement.
  • Assist in preparing quality reports and presentations for management review.
  • Monitor key performance indicators (KPIs) and contribute to achieving quality targets.
• Continuous Improvement:
  • Participate in continuous improvement projects aimed at enhancing quality, reducing waste, and improving efficiency in production processes.
  • Proactively suggest ideas for improving quality systems and processes.
• Supplier Quality Management:
  • Evaluate and monitor suppliers to ensure they meet quality requirements.
  • Conduct audits, manage supplier corrective actions and maintain supplier quality records.
• Training & Collaboration:
  • Assist in training staff on quality standards and quality control best practices.
  • Collaborate with other departments to promote a culture of quality across the organization.
• Documentation & Compliance:
  • Maintain and update quality documentation, including regulatory submissions, compliance files, and product labeling.
  • Ensure all documents are organized, audit-ready, and compliant with Part 820, ISO 13485 and MDSAP.
  • Assist in maintaining regulatory documentation and regulatory findings.
  • Implement and maintain the QMS and (eQMS) to ensure compliance with FDA, ISO 13485 and other relevant regulations and standards.
• Product Lifecycle Management:
  • Monitor post-market performance and compliance with regulatory requirements through activities such as post-market surveillance and vigilance reporting.
• Regulatory Intelligence:
  • Assist in monitoring and interpreting changes in regulatory requirements, including new laws or guidance from the FDA, EU, or other regulatory bodies.
  • Help provide insights on emerging regulations or standards that may impact the company's products.
• Cross-Functional Collaboration:
  • Work with engineering and manufacturing teams to ensure regulatory requirements are understood and implemented during product development and production, assist with risk assessments, design reviews and validate/verification activities.
  • Participate in cross-functional meetings to support regulatory input during design reviews and product launches.
• Internal Audits & Compliance Support:
  • Support internal audits related to regulatory compliance and help in maintaining the quality management system (QMS) in alignment with regulatory requirements.
  • Assist in responding to audit findings or corrective actions related to quality.
  • Provide quality training and support to team members and ensure that best practices are followed across the organization.
• Training & Regulatory Guidance:
  • Provide support in training other departments (such as design engineering, marketing and sales) on regulatory requirements and compliance practices.
  • Ensure adherence to regulatory requirements and industry standards.  Help create guidance materials or training sessions on key quality and regulatory topics.
• Production:
  • Provide support for production, help troubleshoot production issues, clarify work instructions, resolving part/raw material issues, streamline processes.

• Design Controls:
  • Provide support for engineering, new product development and changes to existing products (ECO – Engineering Change Orders). 

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.

Qualifications