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Quality Engineering Techs

Zeiss Inc

As the pioneers of science, ZEISS handles the ever-changing environments in a fast-paced world, meeting it with cutting edge technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. 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.
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.
Audits and Inspections
Conduct internal audits of quality assurance processes, production practices, and calibration records to ensure compliance with established standards.
Participate in external audits and inspections, providing necessary documentation and support to demonstrate compliance with quality standards.
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.
A bachelor's degree in engineering, quality management, or a related field is required.

  • 2-5 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.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
This is a full-time position. Hours of work are generally Monday through Friday, 40 hours per week.

Medical

  • Dental
  • Employee Assistance Programs
  • The above is intended to describe the general content of and requirements for this job. Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).

Vacancy posted 5 days ago
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