Quality Engineer

1 week ago

Yorba Linda, United States Dynaflex Technologies Full time
Job Overview:

We are seeking a motivated and detail-oriented Entry-Level Quality Engineer to join our Quality Assurance team at Dynaflex Technologies Inc, a leading medical device contract manufacturer. The successful candidate will support our manufacturing processes to ensure that our medical devices meet the stringent quality and regulatory standards required by our clients and the healthcare industry. This role is ideal for recent graduates or individuals with some experience in quality engineering who are passionate about improving patient outcomes through high-quality medical devices.

Key Responsibilities:
  • Quality Assurance Support:
  • Assist in the development, implementation, and maintenance of quality control processes and procedures specific to medical device manufacturing.
  • Support the Quality Manager in conducting regular audits and inspections of production lines to ensure compliance with internal and external quality standards.
  • Monitor and analyze product and process performance metrics, focusing on identifying areas for improvement to enhance device safety and effectiveness.
  • Documentation and Reporting:
  • Maintain detailed and accurate records of quality inspections, test results, and audit findings in compliance with regulatory requirements.
  • Prepare comprehensive reports on quality issues, non-conformances, and trends to assist in the continuous improvement of products and processes.
  • Ensure all documentation adheres to the requirements set forth by regulatory bodies such as the FDA and ISO 13485.
  • Problem Solving and Continuous Improvement:
  • Participate in the investigation and resolution of quality-related issues, including customer complaints and internal non-conformances.
  • Collaborate with cross-functional teams to implement corrective actions and preventive measures, ensuring compliance with regulatory requirements.
  • Engage in root cause analysis and problem-solving activities to drive process improvements and reduce variability in manufacturing.
  • Testing and Inspection:
  • Conduct routine inspections and testing of medical devices to ensure they meet client specifications, quality standards, and regulatory requirements.
  • Assist in the calibration, maintenance, and validation of inspection and test equipment used in the quality control process.
  • Support the development and execution of test plans, protocols, and methodologies for both new and existing medical devices.
  • Training and Development:
  • Receive training on quality systems, regulatory requirements, and quality tools specific to medical device manufacturing.
  • Assist in training manufacturing and quality assurance staff on quality standards, procedures, and regulatory compliance.
Qualifications:
  • Education:
  • Bachelor’s degree in Engineering, Quality Assurance, Biomedical Engineering, or a related field.
  • Experience:
  • Previous internship or work experience in a manufacturing or quality assurance role within the medical device industry is preferred but not required.
  • Familiarity with medical device quality management systems (e.g., ISO 13485) and regulatory requirements (e.g., FDA regulations) is a plus.
  • Skills and Competencies:
  • Strong attention to detail and analytical skills, with a focus on compliance and safety.
  • Excellent communication skills, both written and verbal, with the ability to convey complex information clearly.
  • Ability to work collaboratively in a team environment and interact effectively with various departments.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Basic understanding of statistical analysis and quality control tools (e.g., Six Sigma, SPC) is advantageous.
Attributes:
  • Problem-Solving:
  • Demonstrated ability to identify issues, conduct thorough investigations, and contribute to effective solutions in a regulated environment.
  • Adaptability:
  • Willingness to learn and adapt to new technologies, methodologies, and regulatory requirements in the medical device industry.
  • Team Player:
  • Ability to work well with others in a fast-paced, highly regulated environment, contributing to the success of the team and company.
What We Offer:
  • Competitive salary and benefits package.
  • Comprehensive training and development programs focused on medical device manufacturing and quality assurance.
  • Opportunities for career growth and advancement in a rapidly growing industry.
  • A supportive and inclusive work environment committed to quality and patient safety.


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