Medical Device Quality Engineer

Job Description

DynaFlex is seeking a dedicated and detail-oriented Quality Engineer to join our team. This role is crucial for developing, implementing, and maintaining our quality assurance systems to ensure that our medical devices meet both company and regulatory standards. The focus will be in our Dental Sleep Medicine department with the possibility to expand to other divisions.

Responsibilities & Duties

• Quality System Management:
• Develop and implement quality assurance policies and procedures in compliance with ISO1345, FDA regulations, and other relevant standards.
• Conduct regular internal audits to ensure compliance with established quality systems.
• Participate in external audits and manage audit responses and corrective actions.
• Product Development and Validation:
• Work closely with the R&D team to ensure that quality considerations are integrated into the design and development of new products.
• Develop and execute validation protocols for new equipment, processes, and products.
• Conduct risk assessments and develop risk management plans in accordance with ISO1345.
• Process Improvement:
• Analyze production and quality control data to identify trends for improvement.
• Lead root cause analysis and corrective/preventive action (CAPA) processes.
• Implement continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Supplier Quality Management:
• Evaluate and approve supplies based on quality standards.
• Conduct supplier audits and manage supplier quality performance.
• Work with supplies to resolve quality issues and improve supplier quality processes.
• Documentation and Reporting:
• Maintain accurate and detailed records of quality activities, including audit reports, validation protocols, and CAPA documentation.
• Prepare quality reports and present findings to management.
• Ensure all quality documentation is compliant with regulatory and company standards.
• Training and Development:
• Develop and deliver quality-related training programs to employees.
• Stay current with industry and regulatory changes to ensure compliance and best practices.
  

Qualifications & Skills

• Education: Bachelor’s degree in Engineering, or related field.
• Experience: Minimum 5 years’ experience in quality assurance within the medical device field, validation processes, risk management, Lean, and Six Sigma.
• Leadership Skills: Ability to motivate team members and maintain high morale, ensuring that everyone is working towards common goals.
• Strong Knowledge: ISO1345, FDA regulations, and other relevant standards.
• Proficient in: Root cause analysis and CAPA processes.
• Decision-making skills: Analyze situations, solve problems, and implement effective solutions.
• Quality Standards: Commitment to high-quality standards.
• Time Management: Ability to prioritize tasks and multitask effectively.
• Communication: Proficiency in reading, writing, and understanding English.
• Teamwork: Ability to work effectively both in a team environment and independently.
• Reliability: Positive work history and ability to maintain a consistent attendance schedule.
  
  

Join our team at DynaFlex and contribute to our mission of delivering high-quality medical devices. Apply now and be part of a company dedicated to innovation and excellence.

Company Description

DynaFlex competes in five dental related markets; Orthodontics Products, Orthodontic Laboratory Services, Dental Sleep Medicine, Clear Aligners and Digital Office Solutions. We have been serving the industry for over 55 years and take pride in our desire to consistently be the best in what we do. We are proud to say that our products are recognized and used by orthodontists and doctors all over the world due to our high quality standards and excellence in manufacturing. Leading the way is a statement we take to heart and from that we continue to utilize the newest orthodontic technology and advanced manufacturing techniques delivering the highest level of quality and service in the industry.

DynaFlex competes in five dental related markets; Orthodontics Products, Orthodontic Laboratory Services, Dental Sleep Medicine, Clear Aligners and Digital Office Solutions. We have been serving the industry for over 55 years and take pride in our desire to consistently be the best in what we do. We are proud to say that our products are recognized and used by orthodontists and doctors all over the world due to our high quality standards and excellence in manufacturing. Leading the way is a statement we take to heart and from that we continue to utilize the newest orthodontic technology and advanced manufacturing techniques delivering the highest level of quality and service in the industry.