Quality Engineer

About Us

ZEISS is a pioneer in science and technology with over 178 years of innovation. We address global challenges with cutting-edge technologies across diverse portfolios, including Industrial Quality & Research, Medical Technology, Consumer Markets, and Semiconductor Manufacturing Technology. With over 42,000 employees worldwide and more than 4,000 in the US and Canada, ZEISS is committed to making a difference through innovation and collaboration.

Responsibilities

• 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.
• Perform other duties as assigned by management.

Requirements

• A bachelor's degree in engineering, quality management, or a related field is required.
• 2-5 years 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.

Work Environment

The work environment is typically moderate in noise level. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. This job description is not exhaustive, and employees may be required to perform other job-related duties as requested by management.

Schedule

This is a full-time position, generally requiring 40 hours per week, Monday through Friday.

Benefits

• Medical, vision, and dental coverage
• 401k matching
• Employee Assistance Programs
• Vacation and sick pay

Additional benefits are also available.