Quality Engineer - Supplier Assurance

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. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone.

About the role

The Quality Engineer – Supplier Assurance plays a critical role in ensuring the quality, reliability, and compliance of products sourced from external suppliers. This position is responsible for developing, implementing, and maintaining robust supplier quality processes across the supply chain to mitigate risks, drive continuous improvement, and uphold the highest standards of product quality. In this role, you will work closely with suppliers and cross-functional internal teams to evaluate supplier capabilities, monitor quality performance, and lead corrective and preventive actions where needed. You will serve as a key partner in ensuring that supplier-related processes meet regulatory requirements and industry standards. This role has a direct impact on the safety, reliability, and performance of medical devices, supporting the delivery of high-quality products that meet both customer expectations and compliance requirements.

Responsibilities

• Quality Compliance
  • Ensure all quality assurance activities comply with regulatory requirements, industry standards, and the company’s Quality Management System (QMS).
  • Maintain accurate, detailed, and up-to-date records in accordance with documentation and archiving requirements.
  • Continuously assess and improve processes to ensure ongoing compliance with current regulations and standards.
  • Ensure compliance of infrastructure within the Supplier Quality Assurance (SQA) function.
  • Represent supplier quality processes during internal and external audits.
  • Participate in and lead supplier audits.
• Operational Responsibilities
  • Develop, harmonize, and implement quality standards, procedures, inspection instructions, and measurement methods to improve process efficiency.
  • Plan, execute, and evaluate validations and qualifications of processes and methods.
  • Establish, qualify, and release new test equipment, including supporting maintenance planning.
  • Lead risk management activities (e.g., pFMEA, control strategies) for new or updated processes.
  • Provide training and guidance to internal teams to improve quality processes and practices.
  • Collaborate cross-functionally to ensure alignment on requirements, expectations, and feedback.
• Supplier Quality & Performance
  • Own and manage the quality performance of assigned suppliers.
  • Monitor supplier performance, identify gaps, and implement corrective and preventive actions (CAPA).
  • Maintain accurate supplier quality documentation and records.
• Continuous Improvement
  • Identify and implement process improvements to enhance supplier quality and operational efficiency.
  • Support continuous improvement initiatives across supplier quality processes.
  • Train internal teams and suppliers on quality standards and expectations.
  • Stay current on industry best practices and emerging technologies.
• Cross-Functional Collaboration
  • Partner with Purchasing, Production, Quality, and R&D teams to improve the quality of purchased products.
  • Support lifecycle management activities (e.g., change controls, CAPAs, LCM processes).
  • Participate in ongoing professional development to enhance technical and quality expertise.

Requirements

• Education & Experience
  • Bachelor’s degree in Engineering (Mechanical, Electrical, Optical), Life Sciences, or a related field required.
  • Master’s degree preferred.
  • Additional certification in Quality (e.g., CQE) is a plus.
  • Minimum 5+ years of experience in Quality Assurance.
  • Strong understanding of medical device manufacturing processes and products; 2 years of medical device experience.
  • Experience in supplier quality management.
• Skills
  • Hands-on experience with NCR (Non-Conformance Reports) and CAPA processes.
  • Process validations (IQ/OQ/PQ).
  • Strong knowledge of regulatory standards (e.g., ISO, FDA-GMP).
  • Proficiency in statistical analysis and quality methodologies.
  • Strong technical writing and documentation skills.
• Physical Requirements
  • Ability to lift and/or move 5–15 pounds.
  • Frequent standing and walking required.
  • Repetitive hand use (grasping, fine manipulation).
  • Vision requirements include close, distance, peripheral, and depth perception.

Schedule

• Full-time position (40+ hours per week).
• Standard schedule: Monday–Friday, 8:00 AM – 5:00 PM.
• Occasional extended hours may be required based on business needs.

Pay

The annual pay range for this position is $97,800 – $122,300. Actual compensation will be determined based on factors such as job location, scope of the role, candidate qualifications, education, experience, and the complexity or specialization of the position. This role is also eligible for a performance-based bonus.

Benefits

• Medical
• Vision
• Dental
• 401k Matching
• Employee Assistance Programs
• Vacation and sick pay