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Title

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Quality Engineer

Description

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We are looking for a dedicated and detail-oriented Quality Engineer to join our team and play a crucial role in ensuring the quality and reliability of our products. In this position, you will be responsible for developing, implementing, and maintaining quality assurance protocols and standards to guarantee product excellence. Your expertise will help in identifying defects, suggesting improvements, and ensuring compliance with industry standards and customer requirements. Working closely with the product development and manufacturing teams, you will conduct thorough inspections, perform statistical analysis, and lead quality audits to mitigate risks and enhance product performance. Your contributions will be pivotal in maintaining our reputation for high-quality products, achieving customer satisfaction, and driving continuous improvement initiatives. Ideal candidates will possess a strong technical background, excellent problem-solving skills, and a keen eye for detail. Your commitment to quality will ensure that our products not only meet but exceed the expectations of our customers and regulatory bodies.

Responsibilities

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  • Develop and implement quality assurance policies and procedures.
  • Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
  • Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
  • Perform thorough inspections of incoming materials, components, and products to ensure compliance with quality standards.
  • Coordinate with product development and manufacturing teams to ensure quality considerations are integrated into product design and processes.
  • Lead internal audits to ensure compliance with ISO and other regulatory standards.
  • Analyze data to identify areas for improvement in the quality system.
  • Develop, recommend, and monitor corrective and preventive actions.
  • Prepare detailed reports, including statistical analysis, and make recommendations for improvements.
  • Train and mentor junior staff in quality assurance principles and practices.
  • Manage the calibration and maintenance of quality testing equipment.
  • Participate in product development meetings to provide quality assurance input.
  • Monitor risk management activities and ensure compliance with safety standards.
  • Review suppliers and subcontractors' quality systems and processes for compliance.
  • Handle customer complaints and lead root cause analysis investigations.
  • Stay up-to-date with new testing methods, industry trends, and regulatory requirements.
  • Participate in continuous improvement initiatives to enhance product quality and efficiency.
  • Collaborate with external quality assurance auditors and customers' inspectors.

Requirements

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  • Bachelor's degree in Engineering, Quality Assurance, or a related field.
  • Proven experience as a Quality Engineer or similar role.
  • Strong knowledge of quality system standards (e.g., ISO 9001, AS9100).
  • Experience with quality inspection, auditing, and testing.
  • Ability to interpret blueprints, specifications, and diagrams.
  • Proficient in statistical analysis and statistical process control tools.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and interpersonal skills.
  • Experience with Quality Management Software and Tools.
  • Knowledge of manufacturing processes and techniques.
  • Familiarity with risk management and quality assurance control.
  • Ability to lead a team and manage projects.
  • Certification as a Quality Engineer (e.g., CQE) from a recognized organization is preferred.
  • Understanding of lean manufacturing principles.
  • Ability to work in a fast-paced and dynamic environment.
  • Strong organizational and time-management skills.
  • Commitment to continuous education and improvement.
  • Flexibility to adapt to changing priorities and new technologies.

Potential interview questions

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  • Can you describe a time when you identified a significant quality issue and how you addressed it?
  • How do you stay current with the latest industry trends and quality standards?
  • What experience do you have with ISO 9001 and AS9100 quality management systems?
  • How do you approach problem-solving when faced with a quality defect?
  • Can you explain your experience with statistical process control tools?
  • What strategies do you use to ensure compliance with quality standards during product development?
  • How do you handle conflicts with team members or departments regarding quality issues?
  • Describe a project where you led quality improvement initiatives. What was the outcome?
  • How do you manage and prioritize your tasks in a fast-paced environment?
  • What makes you a good fit for this Quality Engineer position?