About Us:
How many companies can say they’ve been in business for over 179 years?!
Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of 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! Make a difference, come join the team!
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
Minimum 5+ years within medical device, pharmaceutical, or healthcare industries
Strong understanding of medical device manufacturing processes and products
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!
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 KhalilZeiss 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).