What's 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.

Sound Interesting?

Here's what you'll do:

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

Do you qualify?

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
• 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

Compensation

• 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.

We have amazing benefits to support you as an employee at ZEISS!

• Medical
• Vision
• Dental
• 401k Matching
• Employee Assistance Programs
• Vacation and sick pay
• The list goes on!

The above is intended to describe the general content of and requirements for this job. It is not to be construed as an exhaustive statement of requirements, duties, or responsibilities. The Company reserves the right to interpret, amend, or otherwise modify, in whole or in part, any job description at any time, at its sole discretion.

Your ZEISS Recruiting Team:
Maria Khalil