Quality Engineer

SUMMARY

The Quality Engineer is responsible for overseeing the quality assurance processes, validations and documentation to ensure compliance with industry standards and regulatory requirements. This role involves managing quality assurance procedures, conducting validations, and implementing continuous improvement initiatives to maintain high-quality standards in manufacturing operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

(Responsibilities that are central to the job and MUST be performed either unaided, or with the assistance of a reasonable accommodation, )

Quality Assurance

• Develop, implement, and maintain comprehensive quality assurance protocols and procedures that align with industry best practices and regulatory requirements.
• Conduct regular reviews of quality metrics and performance indicators to assess the effectiveness of quality assurance processes.
• Collaborate with cross-functional teams to ensure that quality standards are integrated into all stages of production, from design to final inspection.

Regulatory Compliance

• Ensure that all quality assurance processes comply with relevant ISO standards, including ISO 9001 (Quality Management Systems), ISO 13485 (Medical Devices), and ISO 14001 (Environmental Management).
• Stay updated on changes to regulatory requirements and industry standards and implement necessary adjustments to quality assurance practices.
• Prepare for and facilitate external audits by regulatory bodies, ensuring that all documentation and processes are in compliance.

Process Improvement

• Identify areas for improvement in manufacturing processes through data analysis, process mapping, and stakeholder feedback.
• Lead continuous improvement initiatives, utilizing methodologies such as Six Sigma, Lean Manufacturing, or Kaizen to enhance product quality and operational efficiency.
• Monitor the effectiveness of implemented improvements and adjust strategies as needed to achieve desired outcomes.

Audits and Inspections

• Conduct internal audits of quality assurance processes, production practices, and calibration records to ensure compliance with established standards.
• Prepare detailed audit reports outlining findings, recommendations, and corrective actions, and follow up to ensure timely resolution of identified issues.
• Participate in external audits and inspections, providing necessary documentation and support to demonstrate compliance with quality standards.

Documentation

• Maintain accurate and up-to-date records of quality assurance processes, validation activities, audit findings, and corrective actions.
• Develop and update standard operating procedures (SOPs) related to quality assurance and validation, ensuring that all documentation is accessible and compliant with regulatory requirements.
• Ensure that all quality-related documentation is properly archived and retrievable for audits and inspections.

Root Cause Analysis

• Lead investigations into quality issues, utilizing root cause analysis techniques such as the 5 Whys, Fishbone Diagram, or Failure Mode and Effects Analysis (FMEA).
• Develop and implement corrective and preventive actions (CAPA) based on investigation findings to address quality concerns and prevent future occurrences.
• Monitor the effectiveness of CAPA initiatives and report on progress to management and relevant stakeholders.
• Other duties assigned by management

Note:

Essential functions may not be limited to the tasks and responsibilities listed within this section. Ordering of essential functions does not necessarily reflect importance of item.

• A bachelor's degree in engineering, quality management, or a related field is required.
• Minimum of 1 year of experience in quality assurance and validation management in a manufacturing environment.
• Certification in quality management (e.g., ASQ Certified Quality Engineer) is preferred.
• Proficiency in quality assurance methodologies, equipment validations and root cause analysis.
• Comprehensive understanding of ISO standards, including ISO 9001, ISO 13485, and ISO 14001.
• Excellent verbal and written communication skills, with the ability to train and guide production staff.

ADDITIONAL…